Skip to main content
BMJ Clinical Evidence logoLink to BMJ Clinical Evidence
. 2009 Jun 4;2009:2301.

Sleep apnoea

Michael Hensley 1,#, Cheryl Ray 2,#
PMCID: PMC2907765  PMID: 21726484

Abstract

Introduction

Sleep apnoea is the popular term for obstructive sleep apnoea-hypopnoea syndrome (OSAHS). OSAHS is abnormal breathing during sleep that causes recurrent arousals, sleep fragmentation, excessive daytime sleepiness, and nocturnal hypoxaemia. Apnoea may be "central", in which there is cessation of inspiratory effort, or "obstructive", in which inspiratory efforts continue but are ineffective because of upper airway obstruction. OSAHS affects up to 4% of men and 2% of women in the USA, with obesity being a major determinant.

Methods and outcomes

We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatment for severe obstructive sleep apnoea-hypopnoea syndrome? What are the effects of treatment for non-severe obstructive sleep apnoea-hypopnoea syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2008 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found 43 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review we present information relating to the effectiveness and safety of the following interventions: nasal continuous positive airway pressure (CPAP); measures aimed at improving compliance with CPAP; oral appliances; and weight loss.

Key Points

Sleep apnoea is the popular term for obstructive sleep apnoea-hypopnoea syndrome (OSAHS). OSAHS is abnormal breathing during sleep that causes recurrent arousals, sleep fragmentation, daytime sleepiness, and nocturnal hypoxaemia.

  • Apnoea may be "central", in which there is cessation of inspiratory effort, or "obstructive", in which inspiratory efforts continue but are ineffective because of upper airway obstruction.

  • OSAHS affects up to 4% of men and 2% of women in the USA, with obesity being a major determinant.

In people with severe OSAHS, nasal CPAP has been shown to reduce daytime sleepiness compared with control treatments.

  • Although effective, it can be difficult getting people to comply with the prescribed CPAP regimen. Compliance seems no better with variations of CPAP, such as automatically titrated CPAP, bi-level positive airway pressure, patient-titrated CPAP, or CPAP plus humidification. We don't know whether educational or psychological interventions may improve compliance with CPAP.

Oral appliances that produce anterior advancement of the mandible seem to be effective in improving sleep-disordered breathing in people with OSAHS (either severe or non-severe).

  • Oral appliances are probably not as effective as CPAP, and we don't know how well they work in the long term.

We found no sufficient evidence judging the effectiveness of weight loss on OSAHS (either severe or non-severe), although there is consensus that advice about weight reduction is an important component of management of OSAHS.

Nasal CPAP also seems beneficial to people suffering from non-severe OSAHS.

  • Nasal CPAP is less acceptable in people with non-severe OSAHS, and we don't know whether measures aimed at improving compliance effectively increase usage.

Clinical context

About this condition

Definition

Sleep apnoea is the popular term for obstructive sleep apnoea-hypopnoea syndrome (OSAHS). OSAHS is abnormal breathing during sleep that causes recurrent arousals, sleep fragmentation, and nocturnal hypoxaemia. The syndrome includes daytime sleepiness, impaired vigilance and cognitive functioning, and reduced quality of life. Apnoea is the absence of airflow at the nose and mouth for at least 10 seconds, and hypopnoea is a major reduction (>50%) in airflow also for at least 10 seconds. Apnoeas may be "central", in which there is cessation of inspiratory effort, or "obstructive", in which inspiratory efforts continue but are ineffective because of upper airway obstruction. The diagnosis of OSAHS is made when a person with daytime symptoms has significant obstructive sleep-disordered breathing revealed by polysomnography (study of sleep state, breathing, and oxygenation) or by more limited studies (e.g., measurement of oxygen saturation overnight). Criteria for the diagnosis of significant sleep-disordered breathing have not been rigorously assessed, but have been set by consensus and convention. Diagnostic criteria have variable sensitivity and specificity. For example, an apnoea/hypopnoea index (AHI) of fewer than five episodes of apnoea or hypopnoea per hour of sleep is considered normal. However, people with upper airway resistance syndrome have an index below five episodes an hour, and many healthy older people have an index greater than five episodes an hour. In an effort to achieve international consensus, new criteria have been proposed and are becoming more widely used. The severity of OSAHS can be classified by the severity of two factors: daytime sleepiness (see table 1 ) and AHI (see table 2 ). Severe OSAHS is defined as severe sleep-disordered breathing (AHI >30 episodes per hour) plus symptoms of excessive daytime sleepiness (such as Epworth Sleepiness Scale >10 or Multiple Sleep Latency Test <5 minutes — see table 3 ). Central sleep apnoea and sleep-associated hypoventilation syndromes are not covered in this review.

Table 1.

Daytime sleepiness (see text).

Severity of daytime sleepiness Activities when unwanted sleepiness or involuntary sleep occurs Functional effects
Mild Activities that require little attention (e.g., watching TV, reading) Minor impairment of social or occupational function
Moderate Activities that require some attention (e.g., attending concerts, meetings, presentations) Moderate impairment of social or occupational function
Severe Activities that require more active attention (e.g., eating, conversation, walking, driving) Marked impairment of social or occupational function

Table 1.

Apnoea/hypopnoea index (see text).

Severity of sleep-disordered breathing AHI (episodes/hour of sleep)
Mild 5–15
Moderate 15–30
Severe Over 30

AHI, apnoea/hypopnoea index.

Table 1.

Validated outcome measures (see text).

Outcome measure (abbreviation) Description Scoring
Epworth Sleepiness Scale (ESS) Questionnaire developed to measure the general level of sleepiness by the likelihood of falling asleep in 8 common situations The score for each question ranges from 0 (no likelihood of falling asleep) to 3 (highly likely to fall asleep). A lower score indicates less daytime sleepiness in the last week Maximum score: 24 Normal: <11Severe: >16
Multiple Sleep Latency test (MSLT) A daytime sleep laboratory-based test in which the person is asked to try and fall asleep when placed in a quiet dark room for 20 minutes at 2-hourly intervals. Monitoring is by electroencephalography. The time between lights out and sleep onset (sleep latency) is measured in minutes. The mean value of 4–5 test sleeps in the day is calculated. The mean sleep latency is considered an "objective" sleep measure of daytime sleepiness. A reduced score indicates an increase in daytime sleepiness Mean adult sleep latency of less than 5 minutes is indicative of pathological sleepiness Mild: 5–7 minutes Borderline: 8–9 minutes Normal: 10 minutes or more
Maintenance of Wakefulness Test (MWT) Similar to the MSLT, but the person is asked to stay awake for 40 minutes in a dark room Sleep latencies of less than 20 minutes are indicative of pathological sleepiness
Quality of life
Medical Outcomes Survey Short-Form 36 (SF-36) A widely used short-form health survey that measures generic health-related quality of life across various populations. It is a 36-item questionnaire comprising 8 health concepts: physical functioning; role limitations attributable to physical health problems; bodily pain; social functioning; general mental health; role limitations attributable to emotional problems; vitality, energy or fatigue; and general health perceptions Most of the 36 items are scored on a 3–6 point Likert scale. Scaling for different questions includes ranges from excellent to poor; limited a lot to not limited at all; not at all to extremely; and others. A higher score reflects a better health-related quality of life
General Health Questionnaire – 28 (GHQ–28) A self-administered screening test, designed to identify short-term changes in mental health. The most popular of the GHQ, it has 28 questions, 7 in each subscale of depression, anxiety, social dysfunction, and somatic symptoms Four subscores as well as a total score are obtained. The higher the score, the more severe the condition. A 4-point scoring system ranges from a "better/healthier than normal" option, through a "same as usual" and a "worse/more than usual" to a "much worse/more than usual" option
Hospital Anxiety and Depression scale (HADS) A 14-item questionnaire designed to identify clinical depression and anxiety. 7 items conceptually assess depression and 7 items were derived from psychic manifestations of anxiety neurosis Overall level of severity of each mood on a 4-point scale (0–3). A score of 8 is clinically significant, a score of 11 or more is highly clinically significant
Beck Depression Inventory (BDI) A measurement of clinical depression with 21 statements regarding a symptom associated with depression (e.g., appetite, mood, sense of failure) Scores range from 0, indicating the absence of the particular symptom, to 3 for most severe
Profile of Mood States (POMS) A self-report designed to measure 6 dimensions of mood, which include: tension–anxiety; depression–dejection; anger–hostility; vigour–activity; fatigue–inertia; and confusion–bewilderment. It consists of 65 short phrases describing feeling and mood, with respondents asked to indicate mood reactions for the "past week including today" or for shorter periods such as "right now" A 5-point Likert type scale ranging from 0 for no mood reaction to 5 for extreme mood reaction
University of Wales Institute of Science and Technology (UWIST) Mood adaptive checklist (UMACL) A measurement of mood with 4 subscales: hedonic tone, anger, tense arousal, and energetic arousal. Except for anger, which only has positively loaded items, each one is made up of a combination of positively and negatively loaded items The final score is the result of adding the positively loaded answers and subtracting the negatively loaded answers
Nottingham Health Profile (NHP) Generic health-related quality-of-life measure made up of 38 items that can be used to produce scores for 6 domains of health, including: physical mobility (8 items), pain (8 items), social isolation (5 items), emotional reactions (9 items), energy (3 items), and sleep (5 items) Yes/no answers and domain scores ranging from 0 to 100 Mean score is calculated across all items within each domain. Overall score is the mean across all items. The higher the score the greater the health problem
Functional Outcomes of Sleep Questionnaire (FOSQ) A sleep-specific functional measure designed to evaluate the impact of sleep disorders and excessive sleepiness. 35 items represent 5 subscales: activity level, vigilance, intimacy and sexual relationships, general productivity, and social outcome Individual scores of each subscale are obtained and summated to produce a global score. The lower the score the greater the dysfunction as a result of sleepiness. 4 levels of response: no difficulty, a little, moderate, or extreme plus non-participation. Scored on a 5-point Likert scale
Cognitive performance measures
SteerClear (SC) A computer program designed to simulate a long, mundane highway drive and to characterise the decrements in driving ability. The person is required to avoid obstacles that randomly appear on a 2-lane highway by pressing a single computer key. Performance on this 30-minute task is reflected by the number of obstacles passed and the number hit Reducing the number of obstacles hit reflects improved vigilance
Trailmaking B tests (TMT-B) A test for broad cognitive performance that uses the connect-a-dot concept requiring the person to draw lines from circle to circle to consecutively link numbers and letters in the quickest time possible Better cognitive performance is indicated by a reduction in score, which reflects the time taken to complete the task
Digit Symbol Substitution (DSS) Cognitive speed is tested by matching individually presented symbols to their numbers using a reference key Improved speed of performance is reflected by an increased score
Paced Auditory Serial Addition Task – 2 second timing (PASAT–2) A test of auditory attention and concentration by evaluating the time taken to add up numbers presented every 2 seconds An increase in the score indicates improved ability to maintain concentration under distraction

Incidence/ Prevalence

The Wisconsin Sleep Cohort Study (>1000 people; mean age 47 years) in North America found prevalence rates for an AHI of more than five episodes an hour of 24% in men and 9% in women, and for OSAHS with an index greater than five episodes an hour plus excessive sleepiness of 4% in men and 2% in women. There are international differences in the occurrence of OSAHS, of which obesity is considered to be an important determinant. Ethnic differences in prevalence have also been found after adjustment for other risk factors. Little is known about the incidence in resource-poor countries.

Aetiology/ Risk factors

The site of upper airway obstruction in OSAHS is around the level of the tongue, soft palate, or epiglottis. Disorders that predispose to either narrowing of the upper airway or reduction in its stability (e.g., obesity, certain craniofacial abnormalities, vocal cord abnormalities, enlarged tonsils, and enlarged tongue) have been associated with an increased risk of OSAHS. It has been estimated that a 1 kg/m2 increase in BMI (3.2 kg for a person 1.8 m tall) leads to a 30% increase (95% CI 13% to 50%) in the relative risk of developing abnormal sleep-disordered breathing (AHI 5 or more episodes/hour) over a period of 4 years. Other strong associated risk factors include increasing age, and sex (male to female ratio is 2:1). Weaker associations include menopause, family history, smoking, and night-time nasal congestion.

Prognosis

The long-term prognosis of people with untreated severe OSAHS is poor quality of life, likelihood of motor vehicle accidents, hypertension, and possibly CVD and premature mortality. Unfortunately, the prognosis of treated OSAHS is unclear. The limitations in the evidence include bias in the selection of participants, short duration of follow-up, and variation in the measurement of confounders (e.g., smoking, alcohol use, and other cardiovascular risk factors). Treatment is widespread, making it difficult to find evidence on prognosis for untreated OSAHS. Observational studies support a causal association between OSAHS and systemic hypertension, which increases with the severity of OSAHS (OR 1.21 for non-severe OSAHS to 3.07 for severe OSAHS). OSAHS increases the risk of motor vehicle accidents three- to sevenfold. It is associated with increased risk of premature mortality, CVD, and impaired neurocognitive functioning.

Aims of intervention

To minimise or eliminate symptoms of daytime sleepiness; to improve vigilance and quality of life; to reduce or abolish the increased risk of motor vehicle accidents and cardiovascular events; to enhance compliance with treatment; to minimise adverse effects of treatment.

Outcomes

Mortality; symptom severity (including daytime sleepiness, intermediate outcomes, cognitive performance, and quality of life); morbidity: for example, road traffic accidents, hypertension, changes in blood pressure, stroke, cardiac failure, and ischaemic heart disease; compliance: hours of usage of treatment; adverse effects. Here, we have included daytime sleepiness, intermediate outcomes, cognitive performance, and quality of life under symptom severity: details of validated outcome measures for daytime sleepiness, quality of life, and cognitive performance are listed in table 3 . Daytime sleepiness is measured using subjective and objective measures, such as the Epworth Sleepiness Scale, Multiple Sleep Latency Test, and Maintenance of Wakefulness Test (see table 3 ). Intermediate outcomes: Measures of the degree of disturbed breathing during sleep, such as the number of apnoeas and hypopnoeas an hour (AHI), the frequency of arousals, and the degree of sleep fragmentation. Quality of life: General measures such as the Medical Outcomes Study: 36-item Short Form Health Survey (SF-36) and the General Health Questionnaire; measures of mood, such as the Hospital Anxiety and Depression Scale, the Beck Depression Inventory, and the Profile of Mood States; measures of energy and vitality such as the SF-36 energy scale, the UWIST Mood Adjective Checklist, and the energy and vitality scale of the Nottingham Health Profile. Disease-specific quality-of-life measures include the Functional Outcomes of Sleep Questionnaire (see table 3 ). Cognitive performance measures: Steer Clear, Trailmaking Test B, Digit Symbol Substitution, and Paced Auditory Serial Addition Task — 2-Second Timing (see table 3 ).

Methods

Clinical Evidence search and appraisal May 2008. The following databases were used to identify studies for this systematic review: Medline 1966 to May 2008, Embase 1980 to May 2008, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2008, Issue 2. Additional searches were carried out using the NHS Centre for Reviews and Dissemination (CRD) website — for the Database of Abstracts of Reviews of Effects (DARE) and the Health Technology Assessment (HTA) database. We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the contributor for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews and RCTs, in any language. RCTs had to be least single-blinded where blinding was possible, and contain 20 or more individuals, of whom 80% or more were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as "open", "open label", or not blinded unless blinding was impossible. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. Different RCTs have used slightly different definitions of OSAHS. Many of the identified studies were crossover RCTs. The results of the crossover trials should be viewed with caution, because effects of treatment before crossover may persist after crossover. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).

Table.

GRADE Evaluation of interventions for Sleep apnoea.

Important outcomes Compliance, Morbidity, Mortality, Symptom severity
Studies (Participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of treatment for severe OSAHS?
At least 10 RCTs (at least 536 people) Symptom severity Nasal CPAP versus placebo, sham CPAP, or conservative treatment 4 –2 0 –1 0 Very low Quality points deducted for diagnostic uncertainty and incomplete reporting of results. Directness point deducted for uncertainty about comparators
At least 12 (at least 572 people) Morbidity Nasal CPAP versus placebo, sham CPAP, or conservative treatment 4 0 –1 –2 0 Very low Consistency point deducted for conflicting results. Directness points deducted for inclusion of different range of disease severities and uncertainty about comparators
2 (103) Symptom severity Oral appliances versus control oral appliance, no treatment, or placebo 4 –2 0 –1 0 Very low Quality points deducted for sparse data and poor follow-up. Directness point deducted for inclusion of different range of disease severities
At least 16 RCTs (at least 637 people) Symptom severity Automatically titrated CPAP versus standard CPAP 4 0 –1 –1 0 Low Consistency point deducted for statistical heterogeneity between studies. Directness point deducted for inclusion of different range of disease severities
At least 16 RCTs (at least 637 people) Compliance Automatically titrated CPAP versus standard CPAP 4 –1 –1 –2 0 Very low Quality point deducted for incomplete reporting of results. Consistency point deducted for statistical heterogeneity between studies. Directness points deducted for inclusion of different range of disease severities and definition of outcome
4 (220) Symptom severity Bi-level positive airway pressure versus CPAP 4 0 0 –1 0 Moderate Directness point deducted for inclusion of multiple interventions
4 (220) Compliance Bi-level positive airway pressure versus CPAP 4 0 –1 –1 0 Low Consistency point deducted for conflicting results. Directness point deducted for inclusion of multiple interventions
1 (24) Symptom severity Patient-titrated CPAP versus CPAP 4 –3 0 0 0 Very low Quality points deducted for sparse data, method of randomisation not reported, and high withdrawal rates
1 (24) Compliance Patient-titrated CPAP versus CPAP 4 –3 0 0 0 Very low Quality points deducted for sparse data, method of randomisation not reported, and high withdrawal rates
2 (162) Symptom severity CPAP plus humidification versus CPAP alone 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
2 (162) Compliance CPAP plus humidification versus CPAP alone 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (72) Symptom severity CPAP plus educational/psychological intervention versus CPAP 4 –3 0 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and uncertainty about significance of result
5 (330) Compliance CPAP plus educational/psychological intervention versus CPAP 4 –1 –1 0 0 Low Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results
What are the effects of treatment for non-severe OSAHS?
At least 5 RCTs (at least 326 people) Symptom severity Nasal CPAP versus conservative treatment, sham CPAP, or placebo 4 –1 –1 –1 0 Very low Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results. Directness point deducted for inclusion of range of interventions
9 (449) Symptom severity Oral appliances versus control oral appliance, no treatment, or placebo 4 0 –1 –1 0 Low Consistency point deducted for conflicting results. Directness point deducted for diverse population
10 (380) Symptom severity Oral appliances versus CPAP 4 0 –1 –1 0 Low Consistency point deducted for conflicting results. Directness point deducted for diverse population
1 (68) Symptom severity Adding oral appliances to conservative measures versus adding CPAP to conservative measures 4 –2 0 –1 0 Very low Quality points deducted for sparse data and incomplete reporting. Directness point deducted for inclusion of range of interventions
1 (68) Morbidity Adding oral appliances to conservative measures versus adding CPAP to conservative measures 4 –2 0 –1 0 Very low Quality points deducted for sparse data and incomplete reporting. Directness point deducted for inclusion of range of interventions
1 (34) Symptom severity Mechanical/physical alternatives (automatically titrated CPAP, bi-level positive airway pressure, patient-titrated CPAP, CPAP plus humidification) versus CPAP 4 –1 0 –1 0 Low Quality point deducted for sparse data. Directness point deducted for inclusion of range of interventions
1 (34) Compliance Mechanical/physical alternatives (automatically titrated CPAP, bi-level positive airway pressure, patient-titrated CPAP, CPAP plus humidification) versus CPAP 4 –1 0 –1 0 Low Quality point deducted for sparse data. Directness point deducted for inclusion of range of interventions
1 (93) Symptom severity CPAP plus educational/psychological interventions versus CPAP 4 –3 0 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and high withdrawal rates
1 (100) Compliance CPAP plus educational/psychological interventions versus CPAP 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results

We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.

Glossary

Apnoea

Absence of airflow at the nose and mouth for at least 10 seconds (duration based on consensus). It is sometimes defined indirectly in terms of oxygen desaturation index (impact on pulse oximetry saturation is measured as the number of occasions per hour when oxygen saturation falls by 4% or more). Apnoeas may be "central", in which there is cessation of inspiratory effort, or "obstructive", in which inspiratory efforts continue but are ineffective because of upper airway obstruction.

Apnoea/hypopnoea index (AHI)

The sum of apnoeas and hypopnoeas per hour of sleep. Although the generally accepted cut-off point for "normal" is an index of five episodes per hour, there are several definitions of normal, of which at least four are applicable to the situation of sleep-disordered breathing: levels inside the range found in a "normal" (i.e., healthy) population; levels well removed from those found in a target disorder such as obstructive sleep apnoea-hypopnoea syndrome; levels not associated with a significant risk of disease and disability; and levels for which there is evidence of a significant benefit of treatment.

Bi-level positive airway pressure (bi-level PAP)

Bi-level PAP devices apply a positive pressure to the upper airway through tubing and a face or nasal mask; however, the pressure during expiration (breathing out) may be adjusted separately from the pressure delivered during inspiration (breathing in). Bi-level PAP devices sense when an inspiratory effort is being made, and deliver a higher pressure during inspiration. When flow stops, the pressure returns to the baseline level. This positive pressure wave during inspirations unloads the diaphragm, decreasing the work of breathing. This form of ventilation has been used in long-term treatment of people with chronic respiratory failure because of neuromuscular problems or chest wall abnormalities.

Cognitive behavioural therapy (CBT)

A form of psychological therapy that uses a range of techniques including examination and challenging of unhelpful thoughts, help with changing behaviours, and examination of underlying dysfunctional assumptions.

Continuous positive airway pressure (CPAP)

This involves applying positive pressure from a blower motor to the upper airway through tubing and a soft nasal mask or a facemask. It provides a "pneumatic splint" to the upper airway. Because nasal delivery is the most common in the published literature, we refer to "nasal CPAP".

Excessive daytime sleepiness (EDS)

A condition in which an individual has an overwhelming urge to fall asleep. People with excessive daytime sleepiness feel drowsy and tired, and often nod or doze easily in relaxed or sedentary situations, or fall asleep in situations where they need or want to be fully awake and alert. EDS can interfere with a person's ability to concentrate and perform daily tasks and routines. It can be measured in a sleep laboratory with a Multiple Sleep Latency Test (MSLT) or a Maintenance of Wakefulness Test (MWT), or with questionnaires such as the Epworth Sleepiness Scale (ESS) or Stanford Sleepiness Scale.

Hypopnoea

A major reduction (>50%) in airflow at the nose and mouth for at least 10 seconds. A smaller reduction in airflow may be accepted as hypopnoea if it is associated with either electroencephalographic arousal or a reduction in oxygen saturation of at least 3% to 4%.

Low-quality evidence

Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Moderate-quality evidence

Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

Oral appliance

The term "oral appliance" is generic for devices placed in the mouth to change the position of the mandible, tongue, and other structures in the upper airway to reduce snoring or the upper airway obstruction of obstructive sleep apnoea-hypopnoea syndrome. Specific types are referred to as mandibular advancement devices or splints.

Sleep-disordered breathing (SDB)

This condition includes both obstructive sleep apnoea-hypopnoea syndrome (OSAHS) and the upper airway resistance syndrome (UARS). OSAHS is defined by the presence of apnoeas (no airflow for 10 seconds or more) and hypopnoeas (markedly reduced airflow for 10 seconds or more), combined as the apnoea-hypopnoea index (AHI). UARS is defined by the presence of respiratory effort-related arousal events (RERAs). Features of SDB include snoring, witnessed episodes of absent breathing (apnoeas), abnormal breathing during sleep, nocturnal hypoxaemia, and abnormal sleep architecture. The increasingly accepted single measure of SDB is the respiratory disturbance index (RDI), which is the sum of AHI plus RERAs (and other respiratory events), expressed as the number of events per hour of sleep.

Upper airway resistance syndrome (UARS)

Measurement of inspiratory effort by oesophageal pressure shows recurrent episodes of increased inspiratory effort that maintain stable ventilation but are associated with arousals and sleep fragmentation. These episodes are also referred to as respiratory effort-related arousal events (RERAs). More recent techniques for measuring nasal airflow can show changes consistent with upper airway resistance syndrome without the need for an oesophageal pressure catheter.

Very low-quality evidence

Any estimate of effect is very uncertain.

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

Contributor Information

Michael Hensley, University of Newcastle, Newcastle, NSW, Australia.

Cheryl Ray, Newcastle Sleep Disorders Centre, Royal Newcastle Hospital, Newcastle, NSW, Australia.

References

  • 1.Gastaut H, Tassarini CA, Duron B. Polygraphic study of the episodic diurnal and nocturnal (hypnic and respiratory) manifestations of the Pickwick syndrome. Brain Res 1966;1:167–186. [DOI] [PubMed] [Google Scholar]
  • 2.Bassari AG, Guilleminault C. Clinical features and evaluation of obstructive sleep apnea hypopnea syndrome. In: Kryger MH, Roth T, Dement WC, eds. Principles and practice of sleep medicine. Philadelphia, PA: WB Saunders, 2000:869–878. [Google Scholar]
  • 3.Ross SD, Sheinhait IA, Harrison KJ, et al. Systematic review and meta-analysis of the literature regarding the diagnosis of sleep apnea. Sleep 2000;23:519–532. [PubMed] [Google Scholar]
  • 4.Sackett DL, Straus SE, Richardson WS, et al. Evidence-based medicine. How to practise and teach EBM. Edinburgh, UK: Churchill Livingstone, 2000:69–70. [Google Scholar]
  • 5.National Health and Medical Research Council of Australia. Effectiveness of nasal continuous airway pressure (nCPAP) in obstructive sleep apnoea in adults. National Health and Medical Research Council of Australia, 2000. Available online at http://www.nhmrc.gov.au/publications/synopses/hpr21syn.htm (last accessed 1 May 2009). [Google Scholar]
  • 6.Guilleminault C, Stoohs R, Clerk A, et al. A cause of excessive daytime sleepiness. The upper airway resistance syndrome. Chest 1993;104:781–787. [DOI] [PubMed] [Google Scholar]
  • 7.Lindberg E, Gislason T. Epidemiology of sleep-related obstructive breathing. Sleep Med Rev 2000;4:411–433. [DOI] [PubMed] [Google Scholar]
  • 8.American Academy of Sleep Medicine Task Force (Flemons W, Chair). Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. Sleep 1999;22:667–689. [PubMed] [Google Scholar]
  • 9.Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep 1991;14:540–545. [DOI] [PubMed] [Google Scholar]
  • 10.Carskadon MA, Dement WC, Mitler MM, et al. Guidelines for the Multiple Sleep Latency Test (MSLT): a standard measure of sleepiness. Sleep 1986;9:519–524. [DOI] [PubMed] [Google Scholar]
  • 11.Poceta JS, Timms RM, Jeong DU, et al. Maintenance of Wakefulness Test in obstructive sleep apnea syndrome. Chest 1992;101:893–897. [DOI] [PubMed] [Google Scholar]
  • 12.Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). 1. Conceptual framework and item selection. Med Care 1992;30:473–483. [PubMed] [Google Scholar]
  • 13.Goldberg D. Use of the general health questionnaire in clinical work. Br Med J (Clin Res Ed) 1986;293:1188–1189. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 14.Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 1983;67:361–370. [DOI] [PubMed] [Google Scholar]
  • 15.Beck AT, Ward CH, Mendelson M, et al. An inventory for measuring depression. Arch Gen Psychiatry 1961;4:561–571. [DOI] [PubMed] [Google Scholar]
  • 16.McNair D, Lorr M, Droppleman L. EITS manual for the profile of mood states. San Diego, CA: Educational and Industrial Test Services, 1971. [Google Scholar]
  • 17.Matthews G, Jones DM, Chamberlin AG. Refining the measurement of mood: The UWIST Mood Adjective Checklist. Br J Psychol 1990;81:17–42. [Google Scholar]
  • 18.Hunt SM, McEwen J, McKenna SP. Measuring health stats: a new tool for clinicians and epidemiologists. J R Coll Gen Pract 1985;35:185–188. [PMC free article] [PubMed] [Google Scholar]
  • 19.Weaver TE, Laizner AM, Evans LK, et al. Instrument to measure functional status outcomes for disorders of excessive sleepiness. Sleep 1997;20:835–843. [PubMed] [Google Scholar]
  • 20.Findley LJ, Fabrizio MJ, Knight H, et al. Driving simulator performance in patients with sleep apnea. Am Rev Respir Dis 1989;140:529–530. [DOI] [PubMed] [Google Scholar]
  • 21.Weaver TE. Outcome measurement in sleep medicine practice and research. Part 2: assessment of neurobehavioral performance and mood. Sleep Med Rev 2001;5:223–236. [DOI] [PubMed] [Google Scholar]
  • 22.Young T, Palta M, Dempsey J, et al. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med 1993;328:1230–1235. [DOI] [PubMed] [Google Scholar]
  • 23.Young TB, Peppard P. Epidemiology of obstructive sleep apnea. In: McNicholas WT, Phillipson EA, eds. Breathing disorders in sleep. London, UK: WB Saunders, 2002:31–43. [Google Scholar]
  • 24.Redline S. Morbidity, mortality and public health burden of sleep apnea. In: McNicholas WT, Phillipson EA, eds. Breathing disorders in sleep. London, UK: WB Saunders, 2002:222–235. [Google Scholar]
  • 25.George CFP. Reduction in motor vehicle collisions following treatment of sleep apnoea with nasal CPAP. Thorax 2001;56:508–512. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 26.Patel SR, White DP, Malhotra A, et al. Continuous positive airway pressure therapy for treating sleepiness in a diverse population with obstructive sleep apnea: results of a meta-analysis. Arch Intern Med 2003;163:565–571. [DOI] [PubMed] [Google Scholar]
  • 27.Giles TL, Lasserson TJ, Smith BJ, et al. Continuous positive airways pressure for obstructive sleep apnoea. In: The Cochrane Library, Issue 2, 2008. Chichester, UK: John Wiley & Sons, Ltd. Search date 2005. 16437429 [Google Scholar]
  • 28.Alajmi M, Mulgrew AT, Fox J, et al. Impact of continuous positive airway pressure therapy on blood pressure in patients with obstructive sleep apnea hypopnea: a meta-analysis of randomized controlled trials. Lung 2007;185:67–72. [DOI] [PubMed] [Google Scholar]
  • 29.Bazzano LA, Khan Z, Reynolds K, et al. Effect of nocturnal nasal continuous positive airway pressure on blood pressure in obstructive sleep apnea. Hypertension 2007;50:417–423. [DOI] [PubMed] [Google Scholar]
  • 30.Haentjens P, Van Meerhaeghe A, Moscariello A, et al. The impact of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea syndrome: evidence from a meta-analysis of placebo-controlled randomized trials. Arch Intern Med 2007;167:757–764. [DOI] [PubMed] [Google Scholar]
  • 31.Loredo JS, Ancoli-Israel S, Kim EJ, et al. Effect of continuous positive airway pressure versus supplemental oxygen on sleep quality in obstructive sleep apnea: a placebo-CPAP-controlled study. Sleep 2006;29:564–571. [DOI] [PubMed] [Google Scholar]
  • 32.Bardwell WA, Norman D, Ancoli-Israel S, et al. Effects of 2-week nocturnal oxygen supplementation and continuous positive airway pressure treatment on psychological symptoms in patients with obstructive sleep apnea: a randomized placebo-controlled study. Behav Sleep Med 2007;5:21–38. [DOI] [PubMed] [Google Scholar]
  • 33.Lim W, Bardwell WA, Loredo JS, et al. Neuropsychological effects of 2-week continuous positive airway pressure treatment and supplemental oxygen in patients with obstructive sleep apnea: a randomized placebo-controlled study. J Clin Sleep Med 2007;3:380–386. [PMC free article] [PubMed] [Google Scholar]
  • 34.Barbe F, Mayoralas LR, Duran J, et al. Treatment with continuous airway pressure is not effective in patients with sleep apnea but no daytime sleepiness. A randomised, controlled trial. Ann Intern Med 2001;134:1015–1023. [DOI] [PubMed] [Google Scholar]
  • 35.Jenkinson C, Davies RJO, Mullins R, et al. Comparison of therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised prospective parallel trial. Lancet 1999;353:2100–2105. [DOI] [PubMed] [Google Scholar]
  • 36.Brander PE, Soirinsuo M, Lohela P. Nasopharyngeal symptoms in patients with obstructive sleep apnea syndrome. Effect of nasal CPAP treatment. Respiration 1999;66:128–135. [DOI] [PubMed] [Google Scholar]
  • 37.Robinson GV, Smith DM, Langford BA, et al. Continuous positive airway pressure does not reduce blood pressure in nonsleepy hypertensive OSA patients. Eur Respir J 2006;27:1229–1235. [DOI] [PubMed] [Google Scholar]
  • 38.Hans MG, Nelson S, Luks VG, et al. Comparison of two dental devices for treatment of obstructive sleep apnea syndrome (OSAS). Am J Orthod Dentofacial Orthop 1997;111:562–570. [DOI] [PubMed] [Google Scholar]
  • 39.Gotsopoulos H, Chen C, Qian J, et al. Oral appliance therapy improves symptoms in obstructive sleep apnea: a randomized, controlled trial. Am J Respir Crit Care Med 2002;166:743–748. [DOI] [PubMed] [Google Scholar]
  • 40.Schmidt-Nowara W, Lowe A, Wiegand L, et al. Oral appliance for the treatment of snoring and obstructive sleep apnea: a review. Sleep 1995;18:501–510. [DOI] [PubMed] [Google Scholar]
  • 41.Pitsis AJ, Darendeliler MA, Gotsopoulos H, et al. Effect of vertical dimension on efficacy of oral appliance therapy in obstructive sleep apnea. Am J Respir Crit Care Med 2002;166:860–864. [DOI] [PubMed] [Google Scholar]
  • 42.Haniffa M, Lasserson TJ, Smith I. Interventions to improve compliance with continuous positive airway pressure for obstructive sleep apnoea. In: The Cochrane Library, Issue 2, 2008. Chichester, UK: John Wiley & Sons, Ltd. Search date 2004. [DOI] [PubMed] [Google Scholar]
  • 43.Ayas NT, Patel SJ, Malhotra A, et al. Auto-titrating versus standard continuous positive airway pressure for the treatment of obstructive sleep apnea: results of a meta-analysis. Sleep 2004;27:249–253. [DOI] [PubMed] [Google Scholar]
  • 44.Hukins C. Comparative study of autotitrating and fixed-pressure CPAP in the home: a randomized, single-blind crossover trial. Sleep 2004;27:1512–1517. [DOI] [PubMed] [Google Scholar]
  • 45.Nussbaumer Y, Bloch KE, Genser T, et al. Equivalence of autoadjusted and constant continuous positive airway pressure in home treatment of sleep apnea. Chest 2006;129:638–643. [DOI] [PubMed] [Google Scholar]
  • 46.West SD, Jones DR, Stradling JR. Comparison of three ways to determine and deliver pressure during nasal CPAP therapy for obstructive sleep apnoea. Thorax 2006;61:226–231. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 47.Ballard RD, Gay PC, Strollo PJ. Interventions to improve compliance in sleep apnea patients previously non-compliant with continuous positive airway pressure. J Clin Sleep Med 2007;3:706–712. [PMC free article] [PubMed] [Google Scholar]
  • 48.Duong M, Jayaram L, Camfferman D, et al. Use of heated humidification during nasal CPAP titration in obstructive sleep apnoea syndrome. Eur Respir J 2005;26:679–685. [DOI] [PubMed] [Google Scholar]
  • 49.DeMolles DA, Sparrow D, Gottlieb DJ, et al. A pilot trial of a telecommunications system in sleep apnea management. Med Care 2004;42:764–769. [DOI] [PubMed] [Google Scholar]
  • 50.Lewis KE, Bartle IE, Watkins AJ, et al. Simple interventions improve re-attendance when treating the sleep apnoea syndrome. Sleep Med 2006;7:241–247. [DOI] [PubMed] [Google Scholar]
  • 51.Meurice JCC, Cornette A, Philip-Joet F, et al. Evaluation of autoCPAP devices in home treatment of sleep apnea/hypopnea syndrome. Sleep Med 2007;8:695–703. [DOI] [PubMed] [Google Scholar]
  • 52.Shneerson J, Wright J. Lifestyle modification for obstructive sleep apnoea. In: The Cochrane Library, Issue 2, 2008. Chichester, UK: John Wiley & Sons, Ltd. Search date 2007. 11279768 [Google Scholar]
  • 53.Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA 2004;292:1724–1737. [DOI] [PubMed] [Google Scholar]
  • 54.Barvaux VA, Aubert G, Rodenstein DO. Weight loss as a treatment for obstructive sleep apnoea. Sleep Med Rev 2000;4:435–452. [DOI] [PubMed] [Google Scholar]
  • 55.Peppard PE, Young T, Dempsey J, et al. Longitudinal study of moderate weight change and sleep-disordered breathing. JAMA 2000;284:3015–3021. [DOI] [PubMed] [Google Scholar]
  • 56.Marshall NS, Barnes M, Travier N, et al. Continuous positive airway pressure reduces daytime sleepiness in mild to moderate obstructive sleep apnoea: a meta-analysis. Thorax 2006;61:430–434. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 57.Monasterio C, Vidal S, Duran J, et al. Effectiveness of continuous positive airway pressure in non-severe sleep apnea-hypopnea syndrome. Am J Respir Crit Care Med 2001;164:939–943. [DOI] [PubMed] [Google Scholar]
  • 58.McArdle N, Devereux G, Heidarnejad H, et al. Long-term use of CPAP therapy for sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med 1999;159:1108–1114. [DOI] [PubMed] [Google Scholar]
  • 59.Lim J, Lasserson TJ, Fleetham J, et al. Oral appliances for obstructive sleep apnoea. In: The Cochrane Library, Issue 2, 2008. Chichester, UK: John Wiley & Sons, Ltd. Search date 2007. 16437488 [Google Scholar]
  • 60.Bloch KE, Iseli A, Zhang JN, et al. A randomized, controlled crossover trial of two oral appliances for sleep apnea treatment. Am J Respir Crit Care Med 2000;162:246–251. [DOI] [PubMed] [Google Scholar]
  • 61.Barnes M, McEvoy RD, Banks S, et al. Efficacy of positive airway pressure and oral appliance in mild to moderate obstructive sleep apnea. Am J Respir Crit Care Med 2004;170:656–664. [DOI] [PubMed] [Google Scholar]
  • 62.Naismith SL, Winter VR, Hickie IB, et al. Effect of oral appliance therapy on neurobehavioral functioning in obstructive sleep apnea: a randomized controlled trial. J Clin Sleep Med 2005;1:374–380. [PubMed] [Google Scholar]
  • 63.Mehta A, Qian J, Petocz P, et al. A randomized controlled study of a mandibular advancement splint for obstructive sleep apnea. Am J Respir Crit Care Med 2001;163:1457–1461. [DOI] [PubMed] [Google Scholar]
  • 64.Hoekema A, Stegenga B, Bakker M, et al. Simulated driving in obstructive sleep apnoea-hypopnoea; effects of oral appliances and continuous positive airway pressure. Sleep Breath 2007;11:129–138. [DOI] [PubMed] [Google Scholar]
  • 65.Lam B, Sam K, Mok WY, et al. Randomised study of three non-surgical treatments in mild to moderate obstructive sleep apnoea. Thorax 2007;62:354–359. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 66.Fritsch KM, Iseli A, Russi EW, et al. Side effects of mandibular advancement devices for sleep apnea treatment. Am J Respir Crit Care Med 2001;164:813–818. [DOI] [PubMed] [Google Scholar]
  • 67.Kushida CA, Morgenthaler TI, Littner MR, et al. Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances: an update for 2005. Sleep 2006;29:240–243. [DOI] [PubMed] [Google Scholar]
  • 68.Ferguson KA, Cartwright R, Rogers R, et al. Oral appliances for snoring and obstructive sleep apnea: a review. Sleep 2006;29:244–262. [DOI] [PubMed] [Google Scholar]
  • 69.Ferguson K. Oral appliance therapy for obstructive sleep apnea. Finally evidence you can sink your teeth into [editorial]. Am J Respir Crit Care Med 2001;163:1294–1295. [DOI] [PubMed] [Google Scholar]
  • 70.Nolan GM, Doherty LS, Mc Nicholas WT. Auto-adjusting versus fixed positive pressure therapy in mild to moderate obstructive sleep apnoea. Sleep 2007;30:189–194. [DOI] [PubMed] [Google Scholar]
  • 71.Jean Wiese H, Boethel C, Phillips B, et al. CPAP compliance: video education may help! Sleep Med 2005;6:171–174. [DOI] [PubMed] [Google Scholar]
  • 72.Richards D, Bartlett DJ, Wong K, et al. Increased adherence to CPAP with a group cognitive behavioral treatment intervention: a randomized trial. Sleep 2007;30:635–640. [DOI] [PubMed] [Google Scholar]
  • 73.Ayappa I, Norman RG, Krieger AC, et al. Non-invasive detection of respiratory effort-related arousals (RERAs) by a nasal cannula/pressure transducer system. Sleep 2000;23:763–771. [DOI] [PubMed] [Google Scholar]
BMJ Clin Evid. 2009 Jun 4;2009:2301.

Nasal CPAP (severe OSAHS)

Summary

In people with severe OSAHS, nasal continuous positive airway pressure (CPAP) has been shown to reduce daytime sleepiness compared with control treatments.

Although effective, it can be difficult getting people to comply with the prescribed CPAP regimen. Compliance seems no better with variations of CPAP, such as automatically titrated CPAP, bi-level positive airway pressure, patient-titrated CPAP, or CPAP plus humidification. We don't know whether educational or psychological interventions may improve compliance with CPAP.

Benefits and harms

Nasal CPAP versus placebo, sham CPAP, or conservative treatment:

We found five systematic reviews (search dates 2001, 2005, and 2006) and three subsequent RCTs. The reviews identified some of the same RCTs, but none completely superseded another and all performed different meta-analyses. Therefore, we report results of all the reviews here. All identified RCTs had problems with their methods and applicability of results; see comment for details.

Symptom severity

Nasal CPAP compared with placebo, sham CPAP, or conservative treatment Nasal CPAP may be more effective at reducing daytime sleepiness and sleep-disordered breathing, but may be no more effective at improving some measures of cognitive performance, in people with severe OSAHS (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Daytime sleepiness

Systematic review
387 people with severe OSAHS plus sleepiness (AHI 30 episodes/hour or more, ESS 11 or more)
6 RCTs in this analysis
Reduction in Epworth Sleepiness Scale (ESS); see table 3 2.2–12 weeks
with nasal CPAP
with control treatments
Absolute results not reported

Reduction in ESS: 4.75
95% CI 2.97 to 6.53
P <0.001
Effect size not calculated nasal CPAP

Systematic review
440 people with severe OSAHS (AHI 30 episodes/hour or more)
7 RCTs in this analysis
Reduction in ESS 4–12 weeks
with nasal CPAP
with control treatments
Absolute results not reported

WMD reduction in ESS: –4.07
95% CI –5.03 to –3.11
P <0.0009
Effect size not calculated nasal CPAP

RCT
3-armed trial
63 people with severe OSAHS Change in ESS from baseline 14 days' treatment
from 11.6 to 8.2 with nasal CPAP
from 12.3 to 10.0 with sham CPAP

Significance not assessed
Intermediate outcomes

RCT
3-armed trial
63 people with severe OSAHS Change in AHI (see table 2 ) and total arousal index from baseline 1–14 days treatment
with nasal CPAP
with sham CPAP
Absolute results reported graphically

P less than or equal to 0.017 for nasal CPAP v sham CPAP
Effect size not calculated nasal CPAP

RCT
3-armed trial
38 people with severe OSAHS Reduction in respiratory disturbance index (RDI)
from 59.4 to 3.6 with nasal CPAP
from 59.3 to 51.0 with sham CPAP

P less than or equal to 0.01 for nasal CPAP v sham CPAP
Effect size not calculated nasal CPAP
Cognitive performance

RCT
3-armed trial
45 people with severe OSAHS Change in Digit Symbol test score (see table 3 ) from baseline to after 14 days' treatment
from 65.8 to 73.8 with nasal CPAP
from 67.6 to 68.7 with sham CPAP

Reported as not significant
P value not reported
Not significant

RCT
3-armed trial
45 people with severe OSAHS Change in Trailmaking B test score (see table 3 ) from baseline to after 14 days' treatment
from 70.8 to 63.4 with nasal CPAP
from 70.3 to 59.6 with sham CPAP

Reported as not significant
P value not reported
Not significant

No data from the following reference on this outcome.

Morbidity

Nasal CPAP compared with placebo, sham CPAP, or conservative treatment We don't know whether nasal CPAP is more effective at reducing blood pressure in people with severe OSAHS (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Diastolic blood pressure

Systematic review
313 people with severe OSAHS (mean AHI >30 episodes/hour)
6 RCTs in this analysis
Reduction in diastolic blood pressure 4–9 weeks
with nasal CPAP
with control treatments
Absolute results not reported

+2.03 mmHg
95% CI +4.1 mmHg to –0.002 mmHg
P = 0.05
Result is of borderline significance
Not significant

Systematic review
248 people with severe OSAHS (mean AHI 42.7 or more)
7 RCTs in this analysis
Change in diastolic blood pressure 4–9 weeks
with nasal CPAP
with control treatment
Absolute results not reported

–1.15 mmHg
95% CI –3.71 mmHg to +1.41 mmHg
Not significant

Systematic review
572 people with OSAHS (any severity); most RCTs included people with severe OSAHS
12 RCTs in this analysis
Change in diastolic blood pressure
with nasal CPAP
with sham CPAP or placebo oral tablet
Absolute results not reported

–1.48 mmHg
95% CI –2.18 mmHg to -0.78 mmHg
P <0.001
Effect size not calculated nasal CPAP
Systolic blood pressure

Systematic review
313 people with severe OSAHS (mean AHI >30 episodes/hour)
6 RCTs in this analysis
Reduction in systolic blood pressure 4–9 weeks
with nasal CPAP
with control treatments
Absolute results not reported

+3.03 mmHg
95% CI +6.7 mmHg to –0.61 mmHg
P = 0.10
Not significant

Systematic review
248 people with severe OSAHS (mean AHI 42.7 or more)
7 RCTs in this analysis
Change in systolic blood pressure 4–9 weeks
with nasal CPAP
with control treatment
Absolute results not reported

–1.22 mmHg
95% CI –4.28 mmHg to +1.83 mmHg
Not significant

Systematic review
572 people with OSAHS (any severity); most RCTs included people with severe OSAHS
12 RCTs in this analysis
Change in systolic blood pressure
with nasal CPAP
with sham CPAP or placebo oral tablet
Absolute results not reported

–1.64 mmHg
95% CI –2.67 mmHg to –0.60 mmHg
P <0.002
Effect size not calculated nasal CPAP
Ambulatory mean blood pressure

Systematic review
572 people with OSAHS (any severity); most RCTs included people with severe OSAHS
12 RCTs in this analysis
Change in 24-hour ambulatory mean blood pressure
with nasal CPAP
with sham CPAP or placebo oral tablet
Absolute results not reported

–1.39 mmHg
95% CI –2.05 mmHg to –0.73 mmHg
P <0.001
Effect size not calculated nasal CPAP

No data from the following reference on this outcome.

Mortality

No data from the following reference on this outcome.

Compliance

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review
440 people with severe OSAHS (AHI 30 episodes/hour or more)
4 RCTs in this analysis
Adverse effects
with nasal CPAP
with control treatment

No data from the following reference on this outcome.

Nasal CPAP versus placebo, sham CPAP, or conservative treatment:

See option on oral appliances in severe OSAHS.

Further information on studies

None.

Comment

Several of the identified RCTs were crossover RCTs that reported no results before crossover. Severity of sleep-disordered breathing (using apnoea/hypopnoea index [AHI], etc.) is not a good guide to severity of daytime sleepiness, which is a major symptom. It is not clear whether the sham or subtherapeutic nasal CPAP used in some placebo groups are truly inactive treatments. Much of the RCT evidence reports only short-term symptomatic outcomes, rather than longer-term complications, such as mortality, motor vehicle accident rate, hypertension, stroke, and ischaemic heart disease. There is also evidence of a significant placebo effect for daytime sleepiness, with one RCT identified by the reviews finding a significant reduction in Epworth Sleepiness Score (ESS) with sham CPAP.

We found one case series (52 consecutive people with severe OSAHS, mean oxygen desaturation index 43/hour), in which the occurrence of nasopharyngeal symptoms was studied systematically before and after nasal CPAP. It found that nasopharyngeal symptoms were common before nasal CPAP in OSAHS (nasal dryness: 74%; sneezing: 51%; blocked nose: 43%; and rhinorrhoea: 37%), and increased during nasal CPAP (sneezing: 75%; and rhinorrhoea: 57%), with greater discomfort in the winter.

Studies with different definitions of OSAHS than that used in this review, and studies in people with OSAHS of varying severity (ranging from mild to severe), have shown different results on blood pressure with CPAP. A small crossover RCT in people with moderate to severe OSAHS confirmed in sleep studies, but without the symptom of daytime sleepiness (32 non-sleepy people [ESS <10], with hypertension [blood pressure >140/90 mmHg] and moderate to severe OSAHS [median >4% oxygen saturation dip rate of 28 dips/hour, range 18 dips/hour to 38 dips/hour]), found that CPAP did not significantly reduce 24-hour blood pressure scores compared with sham CPAP, confirming the findings from an earlier study.

Clinical guide:

Nasal CPAP is the preferred treatment for all people with severe sleep apnoea, which has significant consequences, such as excessive daytime sleepiness, or major comorbidity, such as poorly controlled hypertension.

Substantive changes

Nasal CPAP (severe OSAHS) Three systematic reviews and three subsequent RCTs added comparing nasal CPAP versus placebo, no treatment, or conservative treatment. They found different results on blood pressure with CPAP versus placebo, no treatment, or conservative treatment. They found reduced daytime sleepiness and sleep disturbance, but no significant difference in performance in some neuropsychological test components, with CPAP versus placebo, no treatment, or conservative treatment. Categorisation unchanged (Beneficial).

BMJ Clin Evid. 2009 Jun 4;2009:2301.

Oral appliances (severe OSAHS)

Summary

Oral appliances that produce anterior advancement of the mandible seem to be effective in improving sleep-disordered breathing in people with severe OSAHS.

Oral appliances are probably not as effective as CPAP, and we don't know how well they work in the long term.

Benefits and harms

Oral appliances versus control oral appliance, no treatment, or placebo:

We found two RCTs comparing an oral appliance that produced anterior advancement of the mandible (removable mandibular advancement device) versus oral appliances that did not (control intervention).

Symptom severity

Mandibular advancement devices compared with control appliances that do not advance the mandible Oral appliances that produce anterior advancement of the mandible may be more effective at improving sleep latency and daytime sleepiness at 2–4 weeks in people with severe OSAHS (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Daytime sleepiness

RCT
24 adults with loud snoring and severe OSAHS Epworth Sleepiness Scale (ESS) score (see table 3 ) 2 weeks
–3.8 with mandibular advancement devices
–0.5 with control oral appliance

P <0.005
Effect size not calculated mandibular advancement device

RCT
Crossover design
85 people (including 14 women) with a mean ESS score of 11 Decrease in sleep latency (see table 3 ) 4 weeks
with active mandibular advancement splint
with inactive mandibular advancement splint
Absolute results not reported

Decrease in sleep latency for active v inactive treatment: 1.2 minutes
95% CI 0.3 minutes to 2.1 minutes
Effect size not calculated active mandibular advancement splint

RCT
Crossover design
85 people (including 14 women) with a mean ESS score of 11 Improvement in ESS score
with active mandibular advancement splint
with inactive mandibular advancement splint
Absolute results not reported

Improvement in ESS score for active v inactive treatment: 2 points
95% CI 1 point to 3 points
Effect size not calculated active mandibular advancement splint

RCT
Crossover design
85 people (including 14 women) with a mean ESS score of 11 Proportion of people with normal ESS score
82% with active mandibular advancement splint
62% with inactive mandibular advancement splint
Absolute numbers not reported

P <0.01
Effect size not calculated active mandibular advancement splint

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Compliance

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
Crossover design
85 people (including 14 women) with a mean ESS score (see table 3 ) of 11 Jaw discomfort
with active mandibular advancement splint
with inactive mandibular advancement splint
Absolute results not reported

P <0.0001
Effect size not calculated inactive mandibular advancement splint

RCT
Crossover design
85 people (including 14 women) with a mean ESS score of 11 Tooth tenderness
with active mandibular advancement splint
with inactive mandibular advancement splint
Absolute results not reported

P <0.0001
Effect size not calculated inactive mandibular advancement splint

RCT
Crossover design
85 people (including 14 women) with a mean ESS score of 11 Excessive salivation
with active mandibular advancement splint
with inactive mandibular advancement splint
Absolute results not reported

P <0.05
Effect size not calculated inactive mandibular advancement splint

No data from the following reference on this outcome.

Oral appliances versus nasal CPAP:

We found no systematic review or RCTs comparing oral appliances versus CPAP solely in people with severe OSAHS. See option on oral appliances in non-severe OSAHS.

Further information on studies

None.

Comment

Oral appliances are commonly used for snoring. Many studies involve participants with OSAHS ranging from mild to severe, complicating the interpretation of the effects of oral appliances on either severe or non-severe OSAHS separately. We found one systematic review (search date 1994; 304 people with mean apnoea/hypopnoea index (AHI) in the severe range, but also including people with mild OSAHS; 21 publications; 19 case series). It found that about 70% of people had a 50% or more reduction in AHI. There was insufficient evidence about long-term effectiveness and adverse effects. One small RCT (24 people, AHI ranging from 6 to 47, crossover design) comparing an oral appliance with a small bite opening (4 mm) versus one with a larger opening (14 mm) found no significant difference in sleep-disordered breathing or ESS. See comment on oral appliances in non-severe OSAHS.

Substantive changes

No new evidence

BMJ Clin Evid. 2009 Jun 4;2009:2301.

Measures aimed at improving compliance with nasal CPAP (severe OSAHS)

Summary

We don't know whether measures aimed at improving compliance effectively increase usage of nasal CPAP in people with severe OSAHS.

Benefits and harms

Automatically titrated CPAP versus standard CPAP:

We found two systematic reviews (search dates 2004 and 2003). The first review identified 13 RCTs comparing standard fixed-pressure CPAP versus automatically titrated CPAP. The second review identified nine RCTs, all of which were identified by the first review. However, there were slight differences between the reviews in the inclusion/exclusion criteria and the reporting of outcomes and so we report both reviews here; see further information on studies for additional details of inclusion criteria. We also found three small subsequent RCTs.

Symptom severity

Automatically titrated CPAP compared with CPAP We don't know how automatically titrated CPAP and CPAP compare at reducing daytime sleepiness and sleep-disordered breathing compared with CPAP in people with severe OSAHS (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Sleepiness

Systematic review
178 people with OSAHS
4 RCTs in this analysis
Subjective sleepiness (Epworth Sleepiness Scale [ESS] score; see table 3 )
with automatically titrated CPAP
with CPAP

WMD for ESS –0.43
95% CI –1.55 to +0.68
See further information on studies for methodological weaknesses
Not significant

Systematic review
154 people with OSAHS
5 RCTs in this analysis
Subjective sleepiness (ESS score)
with automatically titrated CPAP
with CPAP
Absolute results not reported

WMD for ESS –0.36
95% CI –1.67 to +0.96
See further information on studies for methodological weaknesses
Not significant

Systematic review
154 people
5 RCTs in this analysis
Mean difference in sleepiness
with automatically titrated CPAP
with CPAP
Absolute results not reported

mean difference in sleepiness –0.56
95% CI –1.4 to +0.3
Not significant

RCT
Crossover design
46 people with severe OSAHS, mean baseline AHI 55 Sleepiness (mean change in ESS score)
7.9 with automatically titrated CPAP
8.4 with CPAP

Reported as not significant
P value not reported
Not significant

RCT
Crossover design
30 people with mean baseline AHI 41.1 Mean reduction in ESS score 1 month
6.1 with automatically titrated CPAP
6.1 with CPAP

Reported as not significant
P value not reported
Not significant

RCT
3-armed trial
78 people with moderate to severe OSAHS; median >4% oxygen saturation dip rate of 34.5 dips/hour, range 10.3 dips/hour to 89.0 dips/hour Reduction in ESS score 1 month
10 with automatically titrated CPAP plus CPAP
10.5 with CPAP
9 with automatically titrated CPAP alone
Absolute results not reported

P = 0.9 (for among-group difference)
Not significant
Intermediate outcomes

Systematic review
277 people
6 RCTs in this analysis
AHI (see table 2 )
with automatically titrated CPAP
with CPAP
Absolute results not reported

WMD –0.34
95% CI –1.20 to +0.52
See further information on studies for methodological weaknesses
Not significant

Systematic review
154 people
5 RCTs in this analysis
Mean difference in AHI
with automatically titrated CPAP
with CPAP
Absolute results not reported

mean difference in AHI –0.20
95% CI –0.74 to +0.35
Not significant

RCT
Crossover design
30 people with mean baseline AHI 41.1 Mean reduction in AHI 1 month
36.5 with automatically titrated CPAP
35.7 with CPAP
Absolute results not reported

P >0.05
Not significant

RCT
Crossover design
30 people with mean baseline AHI 41.1 Mean reduction in oxygen desaturation index (ODI)
24.8/hour with automatically titrated CPAP
25.0/hour with CPAP

Reported as not significant
P value not reported
Not significant

RCT
3-armed trial
78 people with moderate to severe OSAHS; median >4% oxygen saturation dip rate of 34.5 dips/hour, range 10.3 dips/hour to 89.0 dips/hour Median AHI 1 month
4.2 with automatically titrated CPAP plus CPAP
4.4 with CPAP
5.8 with automatically titrated CPAP alone

P = 0.4
Not significant

Compliance

Automatically titrated CPAP compared with CPAP We don't know whether automatically titrated CPAP is more effective at improving compliance in people with severe OSAHS (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Compliance

Systematic review
237 people
5 RCTs in this analysis
Hours of use of CPAP
with automatically titrated CPAP
with CPAP
Absolute results not reported

WMD +0.32 hours/night
95% CI –0.26 hours/night to +0.90 hours/night
There was significant heterogeneity among RCTs; this was possibly attributable to some studies selecting people who would benefit more from automatically titrated CPAP, or who were poorly compliant with CPAP
See further information on studies for methodological weaknesses
Not significant

Systematic review
246 people
8 RCTs in this analysis
Hours of use of CPAP
with automatically titrated CPAP
with CPAP
Absolute results not reported

WMD +0.23 hours
95% CI –0.09 hours to +0.54 hours
There was significant heterogeneity among RCTs; this was possibly attributable to some studies selecting people who would benefit more from automatically titrated CPAP, or who were poorly compliant with CPAP
See further information on studies for methodological weaknesses
Not significant

Systematic review
87 people
4 RCTs in this analysis
Days of use
with automatically titrated CPAP
with CPAP
Absolute results not reported

Percentage of days of use: +3.15%
95% CI –0.96% to +7.27%
Not significant

Systematic review
142 people
4 RCTs in this analysis
Withdrawals
with automatically titrated CPAP
with CPAP
Absolute results not reported

OR 0.59
95% CI 0.12 to 2.88
See further information on studies for methodological weaknesses
Not significant

Systematic review
154 people
5 RCTs in this analysis
Mean difference in nightly usage
with automatically titrated CPAP
with CPAP
Absolute results not reported

mean difference in nightly usage +0.20 hours
95% CI –0.16 hours to +0.57 hours
Not significant

RCT
Crossover design
46 people with severe OSAHS, mean baseline AHI 55 Average nightly usage
5.05 hours with automatically titrated CPAP
4.86 hours with CPAP

P = 0.14
Not significant

RCT
Crossover design
46 people with severe OSAHS, mean baseline AHI 55 Percentage of nights treatment
83% with automatically titrated CPAP
78% with CPAP
Absolute numbers not reported

P = 0.29
Not significant

RCT
Crossover design
30 people with mean baseline AHI 41.1 Mean duration of nightly use
5.1 hours with automatically titrated CPAP
4.8 hours with CPAP

P >0.05
Not significant

RCT
3-armed trial
78 people with moderate to severe OSAHS; median >4% oxygen saturation dip rate of 34.5 dips/hour, range 10.3 dips/hour to 89.0 dips/hour Median number of hours used 1 month
4.3 hours with automatically titrated CPAP plus CPAP
4.7 hours with CPAP
5.3 hours with automatically titrated CPAP alone

P = 0.27 (for among-group difference)
Not significant

RCT
3-armed trial
78 people with moderate to severe OSAHS; median >4% oxygen saturation dip rate of 34.5 dips/hour, range 10.3 dips/hour to 89.0 dips/hour Median percentage of nights used 1 month
98.4% with automatically titrated CPAP plus CPAP
96.6% with CPAP
96.6% with automatically titrated CPAP alone

P = 0.68 (for among-group difference)
Not significant

RCT
Crossover design
30 people with mean baseline AHI 41.1 Patient preference
26/30 (87%) with automatically titrated CPAP
4/30 (13%) with CPAP

P <0.001
Effect size not calculated automatically titrated CPAP

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review
36 people
Data from 1 RCT
Nasal blockage
3/24 (13%) with automatically titrated CPAP
1/12 (8%) with CPAP

Significance not assessed
See further information on studies for methodological weaknesses

Systematic review
46 people
Data from 1 RCT
Discomfort/pressure
with automatically titrated CPAP
with CPAP
Absolute results not reported

P <0.006
See further information on studies for methodological weaknesses
Effect size not calculated automatically titrated CPAP

Systematic review
52 people
Data from 1 RCT
Adverse effects
with automatically titrated CPAP
with CPAP
Absolute results not reported

Reported as not significant
P value not reported
See further information on studies for methodological weaknesses
Not significant

RCT
Crossover design
46 people with severe OSAHS, mean baseline AHI 55 Withdrawals
5/32 (16%) with automatically titrated CPAP
4/23 (17%) with CPAP

Reported as not significant
P value not reported
Not significant

RCT
Crossover design
30 people with mean baseline AHI 41.1 Mean pressure discomfort score (measured on a visual analogue scale of 0–100 mm, lower value indicating more favourable response
8 mm with automatically titrated CPAP
27 mm with CPAP

P <0.05
Effect size not calculated automatically titrated CPAP

No data from the following reference on this outcome.

Bi-level positive airway pressure versus CPAP:

We found one systematic review (search date 2004, 3 RCTs [mean AHI >35]) and one subsequent RCT.

Symptom severity

Bi-level positive airway pressure compared with CPAP Bi-level positive airway pressure seems as effective as CPAP at reducing daytime sleepiness and quality of life in people with severe OSAHS (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Sleepiness

Systematic review
27 people
Data from 1 RCT
Mean Epworth Sleepiness Scale (ESS) score (see table 3 )
7.8 with bi-level positive airway pressure
8.0 with CPAP

WMD –0.20
95% CI –3.44 to +3.04
See further information on studies for methodological weaknesses
Not significant
Quality of life

RCT
104 people with OSAHS (mean AHI about 40; see table 2 ) non-compliant with CPAP therapy (defined as using CPAP for less than 4 hours per night) Quality of life (mean Functional Outcomes of Sleep Questionnaire [FOSQ] score; see table 3 ) 90 days
15.7 with bi-level positive airway pressure
15.8 with CPAP

Reported as not significant
P value not reported
Not significant

Compliance

Bi-level positive airway pressure compared with CPAP We don't know how bi-level positive airway pressure and CPAP compare at improving compliance in people with severe OSAHS (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Compliance

Systematic review
89 people
2 RCTs in this analysis
Duration of nightly use
with bi-level positive airway pressure
with CPAP
Absolute results not reported

WMD –0.08 hours
95% CI –0.55 hours to +0.38 hours
See further information on studies for methodological weaknesses
Not significant

Systematic review
16 people
Data from 1 RCT
Patient preference
40% with bi-level positive airway pressure
40% with CPAP
Absolute numbers not reported

Significance not assessed
See further information on studies for methodological weaknesses

RCT
104 people with OSAHS (mean AHI about 40; see table 2 ) non-compliant with CPAP therapy (defined as using CPAP for less than 4 hours per night) Compliance 90 days
25/51 (49%) with bi-level positive airway pressure
15/53 (28%) with CPAP

P = 0.03
Effect size not calculated bi-level positive airway pressure

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review
83 people
Data from 1 RCT
Overall withdrawal
5/31 (16%) with bi-level positive airway pressure
16/52 (31%) with CPAP

P = 0.05
See further information on studies for methodological weaknesses
Effect size not calculated bi-level positive airway pressure

Systematic review
83 people
Data from 1 RCT
Withdrawals caused by mask discomfort or intolerance to treatment
0/31 (0%) with bi-level positive airway pressure
5/52 (10%) with CPAP

Significance not assessed
See further information on studies for methodological weaknesses

Systematic review
83 people
Data from 1 RCT
Overall adverse effects
with bi-level positive airway pressure
with CPAP
Absolute results not reported

See further information on studies for methodological weaknesses

Systematic review
27 people
Data from 1 RCT
Overall adverse effects
with bi-level positive airway pressure
with CPAP
Absolute results not reported

See further information on studies for methodological weaknesses

No data from the following reference on this outcome.

Patient-titrated CPAP versus CPAP:

We found one systematic review (search date 2004), which identified one small crossover RCT comparing patient-titrated CPAP versus fixed CPAP.

Symptom severity

Patient-titrated CPAP compared with CPAP We don't know how patient-titrated CPAP and CPAP compare at improving sleep-disordered breathing or daytime sleepiness in people with severe OSAHS (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Sleepiness

Systematic review
24 people, mean AHI 65 (see table 2 ), mean Epworth Sleepiness Scale (ESS) score 8.5 (see table 3 )
Data from 1 RCT
ESS score 10 weeks
with patient-titrated CPAP
with CPAP
Absolute results not reported

Difference in mean ESS score –1.4
95% CI –3.1 to +0.4
Results should be interpreted with caution; methodological weaknesses of the RCT included unclear randomisation and high withdrawal rate (6/24 [25%])
Not significant
Intermediate outcomes

Systematic review
24 people, mean AHI 65 (see table 2 ), mean Epworth Sleepiness Scale (ESS) score 8.5 (see table 3 )
Data from 1 RCT
AHI 10 weeks
with patient-titrated CPAP
with CPAP
Absolute results not reported

Difference in mean AHI –4
95% CI –14.5 to +6.5
Results should be interpreted with caution; methodological weaknesses of the RCT included unclear randomisation and high withdrawal rate (6/24 [25%])
Not significant

Compliance

Patient-titrated CPAP compared with CPAP We don't know how patient-titrated CPAP and CPAP compare at improving compliance in people with severe OSAHS (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Compliance

Systematic review
24 people, mean AHI 65 (see table 2 ), mean Epworth Sleepiness Scale (ESS) score 8.5 (see table 3 )
Data from 1 RCT
Mean nightly hours of use 10 weeks
6.4 hours with patient-titrated CPAP
6.7 hours with CPAP

Reported as not significant
P value not reported
Results should be interpreted with caution; methodological weaknesses of the RCT included unclear randomisation and high withdrawal rate (6/24 [25%])
Not significant

Systematic review
24 people, mean AHI 65, mean ESS score 8.5 (
Data from 1 RCT
Percentage of nights use 10 weeks
86% with patient-titrated CPAP
87% with CPAP
Absolute numbers not reported

Reported as not significant
P value not reported
Results should be interpreted with caution; methodological weaknesses of the RCT included unclear randomisation and high withdrawal rate (6/24 [25%])
Not significant

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Withdrawal

Systematic review
24 people, mean AHI 65 (see table 2 ), mean Epworth Sleepiness Scale (ESS) score 8.5 (see table 3 )
Data from 1 RCT
Withdrawal
2/14 (14%) with patient-titrated CPAP
1/10 (10%) with CPAP

RR 1.4
95% CI 0.2 to 13.7
Results should be interpreted with caution; methodological weaknesses of the RCT included unclear randomisation and high withdrawal rate (6/24 [25%])
Not significant

CPAP plus humidification versus CPAP alone:

We found one systematic review (search 2004, 1 RCT) and one subsequent RCT comparing CPAP alone versus CPAP plus heated humidification.

Symptom severity

CPAP plus humidification compared with CPAP alone We don't know how CPAP plus humidification and CPAP alone compare at improving quality of life, nasal resistance, or nasopharyngeal symptoms in people with severe OSAHS (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Symptom severity

RCT
70 people with mild to severe OSAHS; baseline AHI 43.5 Frequency or severity of nasopharyngeal symptoms
with CPAP plus humidification
with CPAP alone
Absolute results not reported

P >0.05
Not significant

RCT
70 people with mild to severe OSAHS; baseline AHI 43.5 Therapeutic pressure
with CPAP plus humidification
with CPAP alone
Absolute results not reported

P >0.05
Not significant

RCT
70 people with mild to severe OSAHS; baseline AHI 43.5 Subjective response to CPAP treatment
with CPAP plus humidification
with CPAP alone
Absolute results not reported

P >0.05
Not significant

Systematic review
54 people; mean baseline AHI: 50 in CPAP alone group v 42 in CPAP plus humidification group
Data from 1 RCT
Quality of life and nasal resistance
with CPAP plus humidification
with CPAP
Absolute results not reported

Reported as not significant
P value not reported
See further information on studies for methodological weaknesses
Not significant

Compliance

CPAP plus humidification compared with CPAP alone We don't know how CPAP plus humidification and CPAP alone compare at improving compliance in people with severe OSAHS (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Compliance

Systematic review
54 people; mean baseline AHI (see table 2 ): 50 in CPAP alone group v 42 in CPAP plus humidification group
Data from 1 RCT
Number of hours of nightly use
4.7 hours with CPAP plus humidification
4.5 hours with CPAP

Reported as not significant
P value not reported
See further information on studies for methodological weaknesses
Not significant

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review
54 people; mean baseline AHI: 50 in CPAP alone group v 42 in CPAP plus humidification group
Data from 1 RCT
nasal symptoms
with CPAP plus humidification
with CPAP
Absolute results not reported

P <0.05
See further information on studies for methodological weaknesses
Effect size not calculated CPAP plus humidification

No data from the following reference on this outcome.

CPAP plus educational/psychological intervention versus CPAP:

We found one systematic review (search date 2004) and two subsequent RCTs. The review identified three RCTs that met Clinical Evidence inclusion criteria (3 RCTs did not meet criteria owing to small size or high withdrawal rates). The RCTs used a variety of interventions, predominantly in people with severe OSAHS. The educational/psychological interventions were implemented to make the person more aware of the reasons for using CPAP, to provide support and encouragement to continue with CPAP, or both. These interventions included cognitive behavioural therapy (CBT), educational material (e.g., videos or pamphlets), telephone support, and information sessions, alone or in combination.

Symptom severity

CPAP plus educational/psychological interventions compared with CPAP alone We don't know how CPAP plus educational/psychological interventions and CPAP alone compare at improving daytime sleepiness in people with severe OSAHS (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Sleepiness

RCT
72 people with moderate to severe OSAHS (mean AHI 42.5 before CPAP titration) Daytime sleepiness (Epworth Sleepiness Scale [ESS]) 1–6 months
with CPAP plus intensive early support
with CPAP plus basic support
Absolute results not reported

Reported as not significant
P value not reported
Results should be interpreted with caution; differences in attendance rates between groups may have affected the reliability of the data (see further information on studies for details)
Not significant

No data from the following reference on this outcome.

Compliance

CPAP plus educational/psychological interventions compared with CPAP alone We don't know how CPAP plus educational/psychological interventions and CPAP alone compare at improving compliance in people with severe OSAHS (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Compliance

Systematic review
80 people, mean AHI 58 (see table 2 )
Data from 1 RCT
Mean nightly CPAP usage
5.4 hours with CPAP plus intensive support
3.8 hours with CPAP plus basic support

P = 0.003
Effect size not calculated CPAP plus intensive support

Systematic review
108 people, mean baseline AHI: 45 in intensive support group v 52 in basic support group
Data from 1 RCT
Mean nightly CPAP use 12 weeks
5.3 hours with CPAP plus intensive support
5.3 hours with CPAP plus basic support

Reported as not significant
P value not reported
Not significant

Systematic review
40 people, mean baseline AHI 49.4, and mean Epworth Sleepiness Scale (ESS) score 10.9
Data from 1 RCT
Mean nightly use of CPAP
7.1 hours with additional literature
5.7 hours with telephone calls
4.4 hours with no additional support

Reported as not significant
P value not reported
Not significant

RCT
30 people starting CPAP, mean baseline AHI about 40 Nightly use of CPAP
4.4 hours with interactive computerised telephone-linked communication system providing education and reinforcement to improve compliance
2.9 hours with usual care

P = 0.076
The RCT may have been too small to detect a clinically important difference
Not significant

RCT
72 people with moderate to severe OSAHS (mean AHI 42.5 before CPAP titration) CPAP nightly use 1 month
5.2 hours with CPAP plus intensive early support
5.4 hours with CPAP plus standard support

Reported as not significant
P value not reported
Results should be interpreted with caution; differences in attendance rates between groups may have affected the reliability of the data (see further information on studies for details)
Not significant

RCT
72 people with moderate to severe OSAHS (mean AHI 42.5 before CPAP titration) CPAP nightly use 6 months
4.9 hours with CPAP plus intensive early support
4.5 hours with CPAP plus standard support

Reported as not significant
P value not reported
Results should be interpreted with caution; differences in attendance rates between groups may have affected the reliability of the data (see further information on studies for details)
Not significant

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
72 people with moderate to severe OSAHS (mean AHI 42.5 before CPAP titration) Mean side effects score (composite score [range 0–27, higher score indicates more severe difficulty]) 1 month
6.8 with CPAP plus intensive early support
9.3 with CPAP plus standard support

P = 0.05
Result is of borderline significance
Results should be interpreted with caution; differences in attendance rates between groups may have affected the reliability of the data (see further information on studies for full details)
Not significant

RCT
72 people with moderate to severe OSAHS (mean AHI 42.5 before CPAP titration) Mean side effects score (composite score [range 0–27, higher score indicates more severe difficulty]) 6 months
with CPAP plus intensive early support
with CPAP plus standard support
Absolute results not reported

Reported as not significant
P value not reported
Results should be interpreted with caution; differences in attendance rates between groups may have affected the reliability of the data (see further information on studies for full details)
Not significant

No data from the following reference on this outcome.

Further information on studies

The systematic review assessed different methods of improving compliance with CPAP for treatment of OSAHS (see comment). The review identified 13 RCTs comparing standard fixed-pressure CPAP versus automatically titrated CPAP. Nine of these RCTs included a population with mean apnoea/hypopnoea index (AHI) and Epworth Sleepiness Scale (ESS) scores in the severe OSAHS range, one RCT had a population with mean AHI of 30, and three RCTs did not provide mean AHI or ESS scores at baseline. The review combined all studies using automatically titrated CPAP, regardless of which machine was used, and of variations in efficacy. It did not distinguish between RCTs in people with severe and non-severe OSAHS. However, it reported that most people in the included RCTs had severe OSAHS. Where possible, the review analysed data from parallel group RCTs and from the pre-crossover results of crossover RCTs together, but post-crossover data separately.

Attendance rates A significantly higher proportion of people from the intensive early support group attended scheduled follow-up appointments compared with standard support at 1 month (failure to attend follow-up appointment at 1 month: 0/36 [0%] with intensive early support v 4/36 [11%] with standard support; P = 0.04). There was no significant difference between groups in the proportion of people attending the follow-up appointment at 6 months (failure to attend follow-up appointment at 6 months: 4/36 [11%] with intensive early support v 10/36 [28%] with standard support; P = 0.07).

Comment

There are numerous designs of automatically titrated CPAP machines that differ in terms of the physiological variable that is monitored — including snoring, apnoea, hypopnoea, airflow limitation, impedance, or a combination of variables — and in terms of the algorithms used to respond to changes in these measures. We found one open-label RCT (83 people with severe OSAHS) comparing treatment with four different automatically titrated CPAP machines versus standard CPAP. It found no significant difference in improvement in clinical symptoms of OSAHS, quality of life, or compliance between groups. If more than 6 hours of CPAP use per night is considered to represent compliance with treatment, then very few people are compliant.

Substantive changes

Measures aimed at improving compliance with nasal CPAP (severe OSAHS) One RCT added comparing ongoing CPAP treatment versus switching to bi-level positive airway pressure treatment. It found improved compliance with switching to bi-level positive airway pressure treatment compared with ongoing CPAP treatment, but no significant difference in quality of life between groups after 90 days. One RCT added comparing intensive early support versus standard support found no significant difference in mean CPAP nightly use or daytime sleepiness between groups at 1 or 6 months' follow-up. Categorisation unchanged (Unknown effectiveness).

BMJ Clin Evid. 2009 Jun 4;2009:2301.

Weight loss (severe OSAHS)

Summary

We found insufficient evidence to assess the effectiveness of weight loss on severe OSAHS, although there is consensus that advice about weight reduction is an important component of management of OSAHS.

Benefits and harms

Weight loss:

We found two systematic reviews (search dates 2007 and 2003), which found no RCTs on the effect of weight loss in people with OSAHS of any severity (see comment).

Further information on studies

None.

Comment

One systematic review (search date 2003) identified non-RCTs and clinical case series on the effects of weight loss surgery on OSAHS. The review included sleep apnoea, sleep-disordered breathing, and pickwickian syndrome in its combined outcome of OSAHS, and did not comment on the severity of OSAHS. It found that OSAHS was significantly improved in the total population (1195 people) undergoing surgery for weight loss, and stratified for each surgical procedure. Another review of the effect of body weight in OSAHS found no RCTs, but included case series in which weight loss, especially that achieved by surgery, was associated with improvement, mainly in people with severe OSAHS. Large relative improvements in the apnoea/hypopnoea index (AHI) (–72% to –98%) were found after 30% to 70% loss from initial weight. Weight loss has the potential to benefit obese people with OSAHS. We found one large population-based cohort study (690 people with sleep-disordered breathing, including those without diagnosis of OSAHS) evaluating sleep-disordered breathing at 4-year intervals over 10 years. It found an association between changes in weight and AHI (weight gain of 10% was associated with an increase in AHI of 32%, 95% CI 20% to 45%; weight loss of 10% was associated with a decrease in AHI of 26%, 95% CI 18% to 34%).

Clinical guide:

There is consensus that advice about weight reduction is an important component of management. However, weight loss is difficult, and advice may need to be combined with nasal CPAP in people with moderate and severe OSAHS.

Substantive changes

No new evidence

BMJ Clin Evid. 2009 Jun 4;2009:2301.

Nasal CPAP (non-severe OSAHS)

Summary

Nasal CPAP seems beneficial to people suffering from non-severe OSAHS.

Nasal CPAP is less acceptable in people with non-severe OSAHS, and we don't know whether measures aimed at improving compliance effectively increase usage.

Benefits and harms

Nasal CPAP versus no treatment:

We found no systematic reviews or RCTs.

Nasal CPAP versus conservative treatment, sham CPAP, or placebo:

We found four systematic reviews, (search date 1999, search date 2001, search date 2005, search date 2004), which identified some of the same RCTs, but none completely superseded another, and all performed different meta-analyses. Therefore, we report all results here. One review reported data on adherence and patient preference. However, data were not comparative; see further information on studies for full details.

Symptom severity

Nasal CPAP compared with conservative treatment, sham CPAP, or placebo Nasal CPAP may be as effective as sham CPAP or placebo at reducing daytime sleepiness and anxiety in people with non-severe OSAHS, but may be more effective at improving functional outcomes, some measures of cognitive performance, and depression (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Sleepiness

Systematic review
208 people with non-severe OSAHS
4 RCTs in this analysis
Daytime sleepiness (mean reduction in Epworth Sleepiness Scale [ESS] score; see table 3 ) at least 4 weeks
with nasal CPAP
with conservative treatment (sleep hygiene and advice about weight reduction) or oral placebo tablets
Absolute results not reported

Mean reduction in ESS: –0.57
95% CI –1.39 to +0.25
Not significant

Systematic review
number of people unclear
3 RCTs in this analysis
Sleep latency (see table 3 ) at least 4 weeks
with nasal CPAP
with conservative treatment (sleep hygiene and advice about weight reduction) or oral placebo tablets
Absolute results reported graphically

Mean effect about 0
95% CI about –0.7 to +0.7
Not significant

Systematic review
number of people unclear
3 RCTs in this analysis
Symptom score (measured with in-house questionnaires using an analogue scale)
with nasal CPAP
with oral placebo tablets
Absolute results not reported

P = 0.006
Effect size not calculated nasal CPAP

Systematic review
326 people with non-severe OSAHS; apnoea/hypopnoea index (AHI) <30; ESS score <11
5 RCTs in this analysis
Daytime sleepiness 4–10 weeks
with nasal CPAP
with control (placebo tablet or sham CPAP, or conservative treatment)
Absolute results not reported

Difference in ESS score +1.10
95% CI –0.13 to +2.32
Not significant

Systematic review
177 people with AHI 15.1–29.9
3 RCTs in this analysis
Sleepiness
with nasal CPAP
with control treatment
Absolute results not reported

Reduction in ESS score –1.71
95% CI –2.49 to –0.92
P <0.05
Effect size not calculated nasal CPAP

Systematic review
165 people with AHI 15.1–29.9
2 RCTs in this analysis
Sleepiness
with nasal CPAP
with control treatment
Absolute results not reported

WMD for ESS score –2.45
95% –4.01 to –0.91
P = 0.002
Effect size not calculated nasal CPAP

Systematic review
418 people; AHI 5–30
7 RCTs in this analysis
Subjective daytime sleepiness 3–24 weeks
with nasal CPAP
with control treatment
Absolute results not reported

ESS score: 1.2 points
95% CI 0.5 points to 1.9 points
P = 0.001
Effect size not calculated nasal CPAP

Systematic review
143 people; AHI 5–30
3 RCTs in this analysis
Objective daytime wakefulness (measured with Maintenance of Wakefulness Test; see table 3 )
with nasal CPAP
with control treatment
Absolute results not reported

2.1 minutes
95% CI 0.5 minutes to 3.7 minutes
P = 0.011
Effect size not calculated nasal CPAP

Systematic review
275 people; AHI 5–30
4 RCTs in this analysis
Objective daytime sleepiness (measured with Sleep Latency Test; see table 3 )
with nasal CPAP
with control treatment
Absolute results not reported

–0.2 minutes
95% CI +1.0 minutes to –0.6 minutes
P = 0.74
Not significant
Cognitive performance

Systematic review
number of people unclear
3 RCTs in this analysis
Cognitive performance (Trailmaking Test B; see table 3 )
with nasal CPAP
with conservative treatment (sleep hygiene and advice about weight reduction) or oral placebo tablets
Absolute results reported graphically

P = 0.003
Effect size not calculated nasal CPAP

Systematic review
number of people unclear
3 RCTs in this analysis
Cognitive performance (Paced Auditory Serial Addition – 2 second timing; see table 3 )
with nasal CPAP
with conservative treatment (sleep hygiene and advice about weight reduction) or oral placebo tablets
Absolute results not reported

P <0.0001
Effect size not calculated nasal CPAP

Systematic review
number of people unclear
2 RCTs in this analysis
Cognitive performance (Steer Clear; see table 3 )
with nasal CPAP
with conservative treatment (sleep hygiene and advice about weight reduction) oral placebo tablets
Absolute results not reported

Reported as not significant
P value not reported
Not significant

Systematic review
number of people unclear
2 RCTs in this analysis
Cognitive performance (Digit Symbol Substitution; see table 3 )
with nasal CPAP
with conservative treatment (sleep hygiene and advice about weight reduction) oral placebo tablets
Absolute results not reported

Reported as not significant
P value not reported
Not significant
Quality of life

Systematic review
number of people unclear
2 RCTs in this analysis
Quality of life (Short Form-36 [SF-36] general perception, Hospital Anxiety and Depression Scale; see table 3 )
with nasal CPAP
with oral placebo tablets
Absolute results not reported

Reported as not significant
P value not reported
Not significant

Systematic review
number of people unclear
3 RCTs in this analysis
Depression (measured with Hospital Anxiety and Depression Scale; see table 3 )
with nasal CPAP
with oral placebo tablets
Absolute results not reported

P = 0.0004
Effect size not calculated nasal CPAP

Systematic review
number of people unclear
2 RCTs in this analysis
Anxiety (measured with Hospital Anxiety and Depression Scale)
with nasal CPAP
with oral placebo tablets
Absolute results not reported

Reported as not significant
P value not reported
Not significant

Systematic review
number of people unclear
2 RCTs in this analysis
Energy and vitality (measured with SF-36 vitality, University of Wales Institute of Science and Technology [UWIST] Mood Adjective Checklist Energetic Arousal Score; see table 3 )
with nasal CPAP
with oral placebo tablets
Absolute results not reported

P = 0.013
Effect size not calculated nasal CPAP

Systematic review
number of people unclear
Data from 1 RCT
Energy/fatigue subscore of medical outcomes
with nasal CPAP
with oral placebo tablets
Absolute results not reported

P <0.05
Effect size not calculated nasal CPAP

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Compliance

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review
People with non-severe and severe OSAHS
4 RCTs in this analysis
Adverse effects
with nasal CPAP
with conservative treatment (sleep hygiene and advice about weight reduction) or oral placebo tablets
Absolute results not reported

Systematic review
68 people with non-severe OSAHS
Data from 1 RCT
Sleep disturbance
8/34 (24%) with CPAP
0/34 (0%) with control

OR 22.13
95% CI 1.22 to 400.93
RCT may have been underpowered to detect a difference in clinically important outcomes
Large effect size control

No data from the following reference on this outcome.

Nasal CPAP versus oral appliances:

See option on oral appliances in non-severe OSAHS.

Further information on studies

One RCT identified by the review found that adherence by people with non-severe OSAHS was moderately high (4.8 hours/day). Treatment acceptance was also reasonable (62% of people who finished the trial chose to continue CPAP).

Comment

Clinical guide:

People with non-severe OSAHS find nasal CPAP less acceptable. People with an AHI below 15 episodes per hour often have half the long-term use of nasal CPAP compared with people with an AHI greater than 15 episodes per hour.

Substantive changes

Nasal CPAP (non-severe OSAHS) One systematic review added comparing CPAP versus control treatments, including oral placebo tablets, sham CPAP, or conservative management. The review found that CPAP improved subjective daytime sleepiness, and objective daytime wakefulness, but did not significantly improve objective daytime sleepiness compared with control after 3 to 24 weeks. Categorisation unchanged (Likely to be beneficial).

BMJ Clin Evid. 2009 Jun 4;2009:2301.

Oral appliances (non-severe OSAHS)

Summary

Oral appliances that produce anterior advancement of the mandible seem to be effective in improving sleep-disordered breathing in people with non-severe OSAHS.

Oral appliances are probably not as effective as CPAP, and we don't know how well they work in the long term.

Benefits and harms

Oral appliances versus control oral appliance, no treatment, or placebo:

We found one systematic review (search date 2007) and three additional crossover RCTs comparing an oral appliance versus no appliance or versus a control appliance. The systematic review (6 RCTs in people with mild to severe sleep apnoea) compared an oral appliance with a control oral appliance. Mean apnoea/hypopnoea index (AHI) measured at baseline was greater than 25 in five RCTs, and 15.3 in the sixth RCT. Subgroup analysis by severity of OSAHS was not possible because of this diverse population. The review analysed AHI and Epworth Sleepiness Scale (ESS) data by RCT design (parallel and crossover studies [before and after crossover]). The three additional RCTs did not report results before crossover.

Symptom severity

Mandibular advancement appliance compared with control appliance or placebo Oral appliances that produce mandibular advancement may be more effective at reducing daytime sleepiness, interference with daily tasks, snoring frequency and loudness, and sleep-disordered breathing, and improving performance ability and energy levels, in people with mild to severe OSAHS (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Sleepiness

Systematic review
130 people
4 RCTs in this analysis
Daytime sleepiness
with active oral appliance
with control oral appliance
Absolute results not reported

Reduction in Epworth Sleepiness Scale (ESS) score (see table 3 ): WMD –2.09
95% CI –3.8 to –0.37
Effect size not calculated oral appliance

Systematic review
182 people
2 RCTs in this analysis
Daytime sleepiness
with active oral appliance
with control oral appliance
Absolute results not reported

Reduction in ESS score: WMD –1.81
95% CI –2.72 to –0.90.
Difference between groups was not significant using a random-effects model (–2.95, 95% CI –6.69 to +0.79)
Effect size not calculated oral appliance

RCT
Crossover design
3-armed trial
24 people; mean AHI 26.7 (see table 2 ) and ESS score 11.9 Daytime sleepiness (ESS) score 1 week
9.0 with first oral appliance that produced mandibular advancement
9.0 with second oral appliance that produced mandibular advancement
13.0 with no treatment

P <0.01 for each oral appliance v no oral appliance
Effect size not calculated oral appliance

RCT
Crossover design
28 people; mean AHI 27 Daytime sleepiness (ESS) score
3.9 with active oral appliance
10.1 with control oral appliance that did not advance the mandible

P <0.01
Effect size not calculated active oral appliance

RCT
Crossover design
85 people with mild to severe OSAHS (mean AHI 26.9) Daytime sleepiness (ESS) score 4 weeks
7.1 with active oral appliance
9.1 with inactive oral appliance

P <0.01
Effect size not calculated active oral appliance
Intermediate outcomes

Systematic review
156 people
5 RCTs in this analysis
Reduction in AHI (see table 2 )
with active oral appliance
with control oral appliance
Absolute results not reported

WMD –10.78
95% CI –15.53 to –6.03
Effect size not calculated oral appliance

Systematic review
155 people
4 RCTs in this analysis
Reduction in AHI
with active oral appliance
with control oral appliance
Absolute results not reported

WMD –15.15
95% CI –19.40 to –10.89
Effect size not calculated oral appliance

RCT
Crossover design
3-armed trial
24 people; mean AHI 26.7 and ESS score 11.9 AHI score 1 week
8.7 with first oral appliance that produced mandibular advancement
7.9 with second oral appliance that produced mandibular advancement
22.6 with no treatment

P <0.05 for appliance v no appliance
Effect size not calculated oral appliance

RCT
Crossover design
28 people; mean AHI 27 AHI score
14 with active oral appliance
30 with control oral appliance that did not advance the mandible

P <0.001
Effect size not calculated active oral appliance

RCT
Crossover design
85 people with mild to severe OSAHS (mean AHI 26.9) Mean AHI
12.2 with active oral appliance
25.4 with inactive oral appliance

P <0.01
Effect size not calculated active oral appliance

RCT
Crossover design
85 people with mild to severe OSAHS (mean AHI 26.9) Mean number of arousals per hour
25.0 with active oral appliance
33.1 with inactive oral appliance

P <0.01
Effect size not calculated active oral appliance
Quality of life

RCT
Crossover design
85 people with mild to severe OSAHS (mean AHI 26.9) Quality of life
17.9 with active oral appliance
15.7 with inactive oral appliance

P <0.05
Effect size not calculated active oral appliance

RCT
Crossover design
85 people with mild to severe OSAHS (mean AHI 26.9) Quality of life
8.8 with active oral appliance
6.9 with inactive oral appliance

P <0.05
Effect size not calculated active oral appliance

RCT
Crossover design
85 people with mild to severe OSAHS (mean AHI 26.9) Quality of life
2.11 with active oral appliance
2.7 with inactive oral appliance

P <0.05
Effect size not calculated active oral appliance

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Compliance

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
Number of people unclear
In review
Adverse effects
with oral appliance
with no appliance or a control appliance
Absolute results not reported

RCT
Crossover design
85 people with mild to severe OSAHS (mean AHI 26.9) intolerance to oral appliance
with active oral appliance
with inactive oral appliance

No data from the following reference on this outcome.

Oral appliances versus CPAP:

We found one systematic review (search date 2005, 9 RCTs) and one subsequent RCT comparing oral appliances versus CPAP in people with OSAHS of varying severity.

Symptom severity

Oral appliances compared with CPAP Oral appliances may be less effective than CPAP at improving sleep-disordered breathing, but we don't know how oral appliances and CPAP compare at improving quality of life in people with OSAHS of varying severity (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Daytime sleepiness

RCT
Crossover design
20 people (AHI 12–93; see table 2 ) Subjective measures of daytime sleepiness (ESS score; see table 3 ) 2–3 months
6.7 with oral appliance
6.0 with CPAP

Reported as not significant
P value not reported
Not significant
Intermediate outcomes

Systematic review
232 people
7 RCTs in this analysis
Change in AHI (see table 2 )
with oral appliance
with nasal CPAP
Absolute results not reported

change in AHI –7.97 episodes/hour
95% CI –9.56 episodes/hour to –6.38 episodes/hour
Effect size not calculated nasal CPAP

RCT
Crossover design
20 people (AHI 12–93) Sleep-disordered breathing (AHI) 2–3 months
5.3 with oral appliance
0 with CPAP

Reported as not significant
P value not reported
Not significant
Quality of life

Systematic review
128 people
2 RCTs in this analysis
Quality of life (assessed using the Functional Outcomes Sleep Questionnaire; see table 3 )
with oral appliance
with nasal CPAP
Absolute results not reported

Difference in score –0.18
95% CI –0.42 to +0.07
Not significant

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Compliance

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review
240 people
4 RCTs in this analysis
Withdrawals
34/121 (28%) with oral appliance
20/119 (17%) with nasal CPAP

OR 0.49
95% CI 0.26 to 0.92
Moderate effect size nasal CPAP

Adding oral appliances to conservative measures versus adding CPAP to conservative measures:

We found one RCT.

Symptom severity

Adding oral appliance to conservative measures compared with adding CPAP to conservative measures Adding oral appliance to conservative measures may be less effective at improving daytime sleepiness and sleep-disordered breathing in people with non-severe OSAHS (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Sleepiness

RCT
3-armed trial
101 people with non-severe OSAHS (mean AHI 21.4); 68 people in analysis Changes in Epworth Sleepiness Scale (ESS) score (see table 3 ) from baseline 10 weeks
from 12 to 9 with oral appliance plus conservative measures
from 12 to 7 with CPAP plus conservative measures

P <0.05
Effect size not calculated CPAP plus conservative measures
Intermediate outcomes

RCT
3-armed trial
101 people with non-severe OSAHS (mean AHI 21.4); 68 people in analysis Change in AHI from baseline 10 weeks
from 20.9 to 10.6 with oral appliance plus conservative measures
from 23.8 to 2.8 with CPAP plus conservative measures

P <0.05
Effect size not calculated CPAP plus conservative measures

RCT
3-armed trial
101 people with non-severe OSAHS (mean AHI 21.4); 68 people in analysis Change in bodily pain score (assessed using SF-36 questionnaire; see table 3 )
from 72.2 to 69.0 with oral appliance plus conservative measures
from 68.0 to 80.5 with CPAP plus conservative measures

P <0.05
Effect size not calculated CPAP plus conservative measures

Morbidity

Adding oral appliance to conservative measures compared with adding CPAP to conservative measures We don't know how adding an oral appliance to conservative measures compares with adding CPAP to conservative measures at improving blood pressure measurements in people with non-severe OSAHS (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Diastolic blood pressure

RCT
3-armed trial
101 people with non-severe OSAHS (mean AHI 21.4); 68 people in analysis Change in morning diastolic blood pressure (mmHg)
from 76.2 to 73.4 with oral appliance plus conservative measures
from 77.0 to 71.8 with CPAP plus conservative measures

Reported as not significant
P values not reported
Not significant

RCT
3-armed trial
101 people with non-severe OSAHS (mean AHI 21.4); 68 people in analysis Change in evening diastolic blood pressure (mmHg)
from 77.8 to 75.9 with oral appliance plus conservative measures
from 78.0 to 74.0 with CPAP plus conservative measures

Reported as not significant
P values not reported
Not significant
Systolic blood pressure

RCT
3-armed trial
101 people with non-severe OSAHS (mean AHI 21.4); 68 people in analysis Change in morning systolic blood pressure (mmHg)
from 127.1 to 125.9 with oral appliance plus conservative measures
from 127.9 to 123.0 with CPAP plus conservative measures

Reported as not significant
P values not reported
Not significant

RCT
3-armed trial
101 people with non-severe OSAHS (mean AHI 21.4); 68 people in analysis Change in evening systolic blood pressure (mmHg)
from 131.9 to 129.8 with oral appliance plus conservative measures
from 130.9 to 124.9 with CPAP plus conservative measures

Reported as not significant
P values not reported
Not significant

No data from the following reference on this outcome.

Mortality

No data from the following reference on this outcome.

Compliance

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
3-armed trial
101 people with non-severe OSAHS (mean AHI 21.4); 68 people in analysis. Adverse effects
with oral appliance plus conservative measures
with CPAP plus conservative measures

Further information on studies

The RCT found that oral appliances significantly reduced interference with daily tasks, and snoring frequency and loudness, and improved performance ability and energy level, compared with no treatment.

A subset of the population (84/101 people) who were overweight (defined as BMI 23 kg/m2 or more) at the beginning of the study were also referred to a weight-control programme; the proportion of people in each arm who received advice on weight control was unclear.

Comment

One small case series (22 people with AHI >5) investigated adverse effects with oral appliances over 12 to 30 months. It found that adverse effects were common (mucosal dryness [86%], tooth discomfort [59%], and hypersalivation [55%]), but did not require discontinuation of treatment.

Oral appliances are commonly used for people who snore, who may or may not have sleep apnoea. Many studies have been undertaken with a study population of people with OSAHS ranging from mild to severe, which complicates the interpretation of the effects of oral appliances on either severe or non-severe OSAHS separately. We found one systematic review (search date 2004, 87 RCTs), which included nine RCTs in which treatment success was analysed by severity of OSAHS. Oral appliances were found to be more effective in people with lower AHI. In non-severe OSAHS, success rates were in the range of 19% to 81%, whereas in people with severe OSAHS, success rates were in the range of 17% to 61%. Although the number and duration of trials are not ideal, the evidence suggests that oral appliances can be effective in people with non-severe OSAHS, with or without daytime sleepiness. See comment in oral appliances in severe OSAHS.

Substantive changes

Oral appliances (non-severe OSAHS) One RCT added comparing active versus inactive oral appliance, which found reduced daytime sleepiness, number of sleep arousals, and sleep-disordered breathing, and improvements in some components of quality of life and depression indices. One RCT added comparing CPAP plus conservative measures versus oral appliance plus conservative measures. It reported reduced sleep-disordered breathing and daytime sleepiness, and improvements in one domain of quality-of-life survey. It found no significant difference in other domains of quality-of-life survey or blood pressure reduction. One RCT added comparing oral appliance versus CPAP, which found no significant difference between groups in sleep-disordered breathing or in subjective measures of daytime sleepiness after 2–3 months. One already included systematic review updated, no new data added. Categorisation unchanged (Likely to be beneficial).

BMJ Clin Evid. 2009 Jun 4;2009:2301.

Measures aimed at improving compliance with nasal CPAP (non-severe OSAHS)

Summary

Nasal CPAP is less acceptable in people with non-severe OSAHS, and we don't know whether measures aimed at improving compliance effectively increase usage.

Benefits and harms

Mechanical/physical alternatives (automatically titrated CPAP, bi-level positive airway pressure, patient-titrated CPAP, CPAP plus humidification) versus CPAP:

We found one systematic review (search date 2004), which identified no RCTs solely in people with non-severe OSAHS. We found one subsequent RCT.

Symptom severity

Automatically titrated CPAP compared with CPAP We don't know how automatically titrated CPAP and CPAP compare at improving sleep-disordered breathing or daytime sleepiness in people with non-severe OSAHS (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Sleepiness

RCT
Crossover design
34 people with mild to moderate OSAHS (AHI <30, mean ESS score >7) Daytime sleepiness (ESS score [see table 3 ]; postcrossover) 8 weeks
7.7 with CPAP
8.6 with automatically titrated CPAP

P = 0.35
Not significant
Intermediate outcomes

RCT
Crossover design
34 people with mild to moderate OSAHS (AHI <30, mean ESS score >7) Sleep-disordered breathing (AHI; postcrossover) 8 weeks
3.5 with CPAP
2.7 with automatically titrated CPAP

P = 0.15
Not significant

Compliance

Automatically titrated CPAP compared with CPAP We don't know how automatically titrated CPAP and CPAP compare at improving compliance in people with non-severe OSAHS (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Compliance

RCT
Crossover design
34 people with mild to moderate OSAHS (AHI <30, mean ESS score >7) Mean nightly use (postcrossover) 8 weeks
4.9 hours with CPAP
4.9 hours with automatically titrated CPAP

P = 0.94
Not significant

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT
Crossover design
34 people with mild to moderate OSAHS (AHI <30, mean ESS score >7) Proportion of people experiencing an adverse effect
with CPAP
with automatically titrated CPAP
Absolute results reported graphically

Reported as not significant
P value not reported
Not significant

CPAP plus educational/psychological interventions versus CPAP:

We found no systematic review, but found two RCTs. One RCT reported on rate of attendance at follow-up appointments: see further information on studies for details.

Symptom severity

CPAP plus educational/psychological interventions compared with CPAP alone CPAP plus educational interventions may be more effective than CPAP alone at reducing daytime sleepiness or improving quality of life in people with non-severe OSAHS (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Sleepiness

RCT
93 people with non-severe OSAHS (mean baseline AHI 9) Daytime sleepiness (ESS) score (see table 3 ) 4 weeks
8.9 with 15-minute educational CPAP video
8.8 with no video

Significance not assessed
Results should be interpreted with caution; difference in withdrawal rates between groups may have affected the results
Quality of life

RCT
93 people with non-severe OSAHS (mean baseline AHI 9) Sleep Apnoea Quality-of-Life score 4 weeks
4.9 with 15-minute educational CPAP video
5.1 with no video

Significance not assessed
Results should be interpreted with caution; difference in withdrawal rates between groups may have affected the results

No data from the following reference on this outcome.

Compliance

CPAP plus educational/psychological interventions compared with CPAP alone CPAP plus psychological intervention may be more effective than CPAP alone at improving compliance in people with non-severe OSAHS (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Compliance

RCT
100 people with mild to severe OSAHS, not previously treated with CPAP Mean hours of nightly use of CPAP 4 weeks
5.4 hours with group cognitive behavioural therapy (CBT)
2.5 hours with usual treatment

P <0.0001
Effect size not calculated CBT

RCT
100 people with mild to severe OSAHS, not previously treated with CPAP Proportion of people using CPAP for 4 or more hours per night
77% with group cognitive behavioural therapy (CBT)
31% with usual treatment
Absolute numbers not reported

Difference 49%
95% CI 30% to 67%
P <0.001
Effect size not calculated CBT

No data from the following reference on this outcome.

Mortality

No data from the following reference on this outcome.

Morbidity

No data from the following reference on this outcome.

Adverse effects

No data from the following reference on this outcome.

Further information on studies

A subset of people (7/29) also received humidification based on clinical circumstances (details not reported), and four people continued with this during the course of the study period. It was not clear to which group these people belonged.

The RCT reported that a significantly larger proportion of people in the group receiving the educational intervention attended follow-up appointments at 4 weeks (73% with 15-minute educational CPAP video v 49% with no video; P = 0.017; absolute numbers not reported).

Comment

None.

Substantive changes

Measures aimed at improving compliance with nasal CPAP (non-severe OSAHS) One RCT added comparing CPAP versus automatically titrated CPAP found no significant difference between groups in sleep-disordered breathing, daytime sleepiness, or compliance after 8 weeks. One RCT added comparing group cognitive behavioural therapy (CBT) versus usual treatment found higher compliance with CPAP in people who received group CBT after 4 weeks of treatment. Categorisation unchanged (Unknown effectiveness).

BMJ Clin Evid. 2009 Jun 4;2009:2301.

Weight loss (non-severe OSAHS)

Summary

We found insufficient evidence to assess the effectiveness of weight loss on OSAHS (either severe or non-severe), although there is consensus that advice about weight reduction is an important component of management of OSAHS.

Benefits and harms

Weight loss:

We found no systematic review or RCTs assessing the effect of weight loss in people with non-severe OSAHS.

Further information on studies

None.

Comment

See comment on weight loss in severe OSAHS.

Substantive changes

No new evidence


Articles from BMJ Clinical Evidence are provided here courtesy of BMJ Publishing Group

RESOURCES