Abstract
Introduction
Sleep disorders may affect between 20% and 30% of young children, and include problems getting to sleep (dyssomnias), or undesirable phenomena during sleep (parasomnias), such as sleep terrors and sleepwalking. Children with physical or learning disabilities are at increased risk of sleep disorders.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for dyssomnias in children? What are the effects of treatments for parasomnias in children? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2009 (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 28 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: antihistamines; behavioural therapy plus antihistamines, plus benzodiazepines, or plus chloral and derivatives; benzodiazepines alone; exercise; extinction and graduated extinction; 5-hydroxytryptophan; light therapy; melatonin; safety/protective interventions for parasomnias; scheduled waking (for parasomnias); sleep hygiene; and sleep restriction.
Key Points
Sleep disorders may affect between 20% and 30% of young children, and include problems getting to sleep (dyssomnias) or undesirable phenomena during sleep (parasomnias), such as sleep terrors and sleepwalking.
Children with physical or learning disabilities are at increased risk of sleep disorders. Other risk factors include the child being the first born, having a difficult temperament or having had colic, and increased maternal responsiveness.
There is a paucity of evidence about effective treatments for sleep disorders in children, especially parasomnias, but behavioural interventions may be the best first-line approach.
Extinction and graduated extinction in otherwise healthy children with dyssomnia may improve sleep quality and settling, and reduce the number of tantrums and wakenings compared with no treatment.
Extinction and graduated extinction in children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorder with dyssomnia may be more effective at improving settling, reducing the frequency and duration of night wakings, and improving parental sleep compared with no treatment; however, we don't know whether it is more effective in improving sleep duration.
Graduated extinction may be less distressing for parents, and therefore may have better compliance.
Sleep hygiene for dyssomnia in otherwise healthy children may be more effective in reducing the number and duration of bedtime tantrums compared with placebo, but we don’t know if it is more effective at reducing night wakenings, improving sleep latency, improving total sleep duration, or improving maternal mood.
Sleep hygiene and graduated extinction seem to be equally effective at reducing bedtime tantrums in otherwise healthy children with dyssomnia.
We don't know whether sleep hygiene for dyssomnia in children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorder is effective.
Melatonin for dyssomnia in otherwise healthy children may be more effective at improving sleep-onset time, total sleep time, and general health compared with placebo.
Evidence of improvements in dyssomnia with melatonin is slightly stronger in children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorder.
Little is known about the long-term effects of melatonin, and the quality of the product purchased could be variable as melatonin is classified as a food supplement.
Antihistamines for dyssomnia may be more effective than placebo at reducing night wakenings and decreasing sleep latency, but we don’t know if they are more effective at increasing sleep duration. The evidence for antihistamines in dyssomnia comes from only one small, short-term study.
We don’t know whether behavioural therapy plus antihistamines, plus benzodiazepines, or plus chloral and derivatives, exercise, light therapy, or sleep restriction are effective in children with dyssomnia.
We don’t know whether antihistamines, behavioural therapy plus benzodiazepines or plus chloral and derivatives, benzodiazepines, 5-hydroxytryptophan, melatonin, safety/protective interventions, scheduled waking, sleep hygiene, or sleep restriction are effective in children with parasomnia.
Clinical context
About this condition
Definition
The International Classification of Sleep Disorders-2 (ICSD-2) defines more than 70 sleep disorders classified into eight major categories: insomnia, sleep-related breathing disorders, hypersomnias of central origin, circadian rhythm sleep disorders, parasomnias, sleep-related movement disorders, isolated symptoms and normal variants, and other sleep disorders. For the purpose of this review we defined dyssomnia including only paediatric insomnia or excessive daytime sleepiness; and parasomnias. Dyssomnia Paediatric insomnia may be defined as difficulty initiating or maintaining sleep that is viewed as a problem by the child or carer. In the ICSD-2, paediatric insomnia is included in the category of "Behavioral Insomnia of Childhood" divided in two types: sleep-onset association type and limit-setting type. Both types of insomnia are common and have an estimated prevalence of 10% to 30%.Sleep-onset association type occurs when a child associates falling asleep with an action (being held or rocked), object (bottle), or setting (parents' bed), and is unable to fall asleep if separated from that association. Limit-setting type occurs when a child stalls and refuses to go to sleep in the absence of strictly enforced bedtime limits. Parasomnias are defined as "undesirable physical events or experiences that occur during entry into sleep, within sleep, or during arousals from sleep." Parasomnias in childhood are common, more often benign, self-limited, and typically resolving in adolescence. Following the ICSD-2, they are subdivided into three groups: disorders of arousal (from NREM sleep); parasomnias usually associated with REM sleep; and other parasomnias. Children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorder: Sleep problems tend to be greater in prevalence and severity in this population. For example, pain is related to sleep disturbance, and attention paid to helping the child sleep better is likely to improve recovery. Across a range of physical problems, there are reports in the literature of sleep disturbance associated with them. In most cases, research is limited and the mechanisms are unclear. Children with visual impairment are prone to circadian rhythm problems: their light perception is poor and the primary cue for sleep onset is therefore lost. Many medications are known to cause sleep problems, such as severe drowsiness with many antiepileptic drugs. Learning disabilities vary considerably in the range of conditions covered by this global term. However, some conditions such as Smith–Magenis, Prader–Willi, and Williams syndrome have sleep disturbance as cardinal features. Others, such as Down's syndrome and mucopolysaccharidoses, are associated with sleep-related breathing problems. Treatment for these groups of children needs to be tailored to their particular problems, and may be problematic for anatomical and neurological reasons. Nevertheless, in large part, these sleep problems should be regarded as treatable, and careful investigation of these problems is required.
Incidence/ Prevalence
Sleep problems, primarily settling problems and frequent night wakings, are experienced by about 20% to 30% of children aged 1 to 5 years, but cultural differences would seem to play at least some role. These sleep disturbances often persist in later childhood: 40% to 80% of children displaying sleep problems when aged 15 to 48 months were found to have persistent sleep disorders 2 to 3 years later. In toddlers, settling and night-waking problems are dominant, with rates about 20% to 25%. A second peak in sleep problems occurs in adolescence, where sleep-timing problems occur, including delayed sleep phase syndrome. Such children have difficulty getting off to sleep, and then problems getting up in the morning for school. Across the age range, sleep-related breathing problems occur at rates about 2%. Children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorder: The prevalence of sleep disorders tends to be even greater in children with physical or learning disabilities: about 86% of children aged up to 6 years, 81% of children aged 6 to 11 years, and 77% of children aged 12 to 16 years with physical or learning disabilities suffer from severe sleep problems.Disorders of initiating and maintaining sleep, prolonged sleep latency, high number of night awakenings, and reduced total sleep time are also found in children with Angelman's syndrome compared with age-matched controls. Furthermore, children with autism are reported to have a shorter sleep duration, a longer sleep latency, and bed wetting compared with controls.
Aetiology/ Risk factors
Evidence of the aetiology of sleep disorders in children is generally limited. The vast majority of insomnia in infancy is behavioural insomnia, without a specific aetiology other than the altered interaction between parents and infants at bedtime.Factors related to sleep disorders are: having had colic, the child being the first born, and the child having a difficult temperament (e.g., low sensory threshold, negative mood, decreased adaptability). Other factors have been suggested, such as being born prematurely and low birth weight; however, evidence of such associations is contradictory.Recently, iron deficiency has also been related to the presence of insomnia, nocturnal hyperactivity, or restless leg syndrome, and therefore this kind of treatment could be considered in some forms of resistant insomnia in infancy and childhood. The factors described here may influence the onset of a sleep disorder, but the factors influencing the maintenance of a sleep problem are likely to be different. Increased maternal responsiveness is associated with the maintenance of sleep disorders in children. Children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorder: Children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorders may have other additional risk factors that include the influence of the specific cerebral lesions, the effect of medications (either antiepileptic drugs or stimulant drugs), the altered circadian phase, etc. Almost all children with brain diseases may be at risk for the development of sleep–wake rhythm disorders. The altered perception of "common zeitgeber" (light–dark cycle, food schedule, maternal inputs, etc.) could lead to the development of irregular sleep habits and even to a free-running rhythm, not related to the 24-hour cycle. Children with learning disabilities or with brain damage/impairments may also exhibit endogenous dysfunction in hormone release. Hormone release synchronises circadian rhythms with sleep/wake alternation and can therefore interfere with the development of a normal sleep–wake cycle. It can be hypothesised that the difficulties in the perception of external stimuli and in their elaboration may be the first step in the development of disrupted sleep–wake organisation.
Prognosis
Children with excessive daytime sleepiness or night waking are likely to suffer from impaired daytime functioning without treatment, and their parents are likely to have increased stress. In addition to these effects, children with parasomnias are at serious risk of accidental injuries. Between 40% and 80% of children aged 15 to 48 months displaying sleep problems had persistent sleep problems 2 to 3 years later. Children with physical disabilities, learning disabilities, epilepsy, or attention-deficit disorder: Children with learning disabilities and sleep disorders are more likely to have greater challenging behaviour than those without sleep problems.This may affect the quality of life of the parents, frequently resulting in parental stress, parents displaying less affection for their children, and marital discord. For children with epilepsy, sleep disorders may exacerbate their condition: a persistent lack of sleep has been associated with an increased frequency of seizures.
Aims of intervention
To improve child and parental satisfaction with sleep; to prevent daytime sleepiness; and improve functional and cognitive ability during the daytime, with minimal adverse effects of treatment.
Outcomes
Dyssomnia and parasomnias: Sleep problems (e.g., difficulty falling asleep, frequent night-time awakenings, bed wetting, etc.); behaviours (e.g., snoring, talking in sleep, etc); quality of life of child measured by, for example, RAND-GHRI, Sleep Behavior Questionnaire; habits (e.g., bed/waking time, daytime naps, sleeping arrangements); quality of life of parent (notably parental sleep). Dyssomnia: Night wakings (frequency and duration); sleep-onset time; sleep-offset time; sleep duration; sleep latency; bedtime tantrums (number and frequency); settling; Composite Sleep Disturbance Score; Compostive Sleep Index Score. Parasomnias: severity of parasomnia; incidence of parasomnia; Adverse effects of treatments.
Methods
Clinical Evidence search and appraisal September 2009. The following databases were used to identify studies for this systematic review: Medline 1966 to September 2009, Embase 1980 to September 2009, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2009, Issue 3 (1966 to date of issue). An additional search within The Cochrane Library was carried out for the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). 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 pre-determined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews of RCTs and RCTs in any language, at least single blinded, and containing more than 20 individuals of whom more than 80% were followed up. We included children aged between aged 2–16 years. 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. We included systematic reviews of RCTs and RCTs where harms of an included intervention were studied applying the same study design criteria for inclusion as we did for benefits. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. 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 (into 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 1.
GRADE evaluation of interventions for sleep disorders in children
| Important outcomes | Sleep onset, duration and quality, parasomnia severity, bedtime tantrums, parental sleep, quality of life of child and carer, adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of treatments for dyssomnias in children? | |||||||||
| 2 (94) | Sleep onset, duration, and quality | Extinction and graduated extinction v no treatment (in otherwise healthy children) | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and poor follow-up |
| 1 (36) | Bedtime tantrums | Graduated extinction v no treatment (in otherwise healthy children) | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and poor follow-up |
| 1 (30) | Sleep onset, duration, and quality | Extinction and graduated extinction v no treatment (in children physical disabilities, learning disabilities, epilepsy or attention-deficit disorder) | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and poor follow-up. Directness point deducted range of disabilities included |
| 1 (30) | Parental sleep | Extinction and graduated extinction v no treatment (in children physical disabilities, learning disabilities, epilepsy or attention-deficit disorder) | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and poor follow-up. Directness point deducted range of disabilities included |
| 1 (200) | Sleep onset, duration, and quality | Sleep hygiene v no treatment (in otherwise healthy children) | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for no direct comparisons between groups and poor follow-up. Directness point deducted for recruitment of mothers only |
| 2 (236) | Quality of life of carer | Sleep hygiene v no treatment (in otherwise healthy children) | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for no direct comparisons between groups, incomplete reporting, and poor follow-up |
| 1 (36) | Bedtime tantrums | Sleep hygiene v no treatment (in otherwise healthy children) | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and poor follow-up |
| 1 (36) | Bedtime tantrums | Sleep hygiene v graduated extinction (in otherwise healthy children) | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and poor follow-up |
| 2 (102) | Sleep onset, duration, and quality | Melatonin v placebo (in otherwise healthy children) | 4 | –3 | 0 | –2 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and poor follow-up. Directness points deducted for uncertainty of measurement of outcome and population differences |
| 1 (62) | Quality of life of child | Melatonin v placebo (in otherwise healthy children) | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and poor follow-up. Directness point inclusion of children with co-morbidities and co-interventions |
| 4 (136) | Sleep onset, duration, and quality of sleep | Melatonin v placebo (in children with ADHD, epilepsy, or neurodevelopmental disorders) | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and for different results with different measures of the same outcome in RCTs of epilepsy. Directness point deducted as clinical importance of difference in outcomes between groups unclear in all RCTs |
| 1 (50) | Sleep onset, duration, and quality | Antihistamines v placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for inclusion of non-recommended dose of antihistamine |
| What are the effects of treatments for parasomnias in children? | |||||||||
| 2 (62) | Parasomnia severity | Melatonin v placebo (in children with epilepsy) | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and poor follow-up. Directness point deducted for broad inclusion criteria |
Type of evidence: 4 = RCT; 2 = Observational; 1 = Non-analytical/expert opinion. Consistency: similarity of results across studies. Directness: generalisability of population or outcomes. Effect size: based on relative risk or odds ratio.
Glossary
- Actigraphy
An actigraph is a motion sensing device. It can be worn on the wrist overnight to provide data when a person falls asleep owing to change in the person's motion.
- Dyssomnias
are disorders that produce either excessive daytime sleepiness or difficulty initiating or maintaining sleep. They can be intrinsic, extrinsic, or circadian rhythm sleep disorders.
- Extinction
involves the removal of the positive reinforcement for the child's resistance to go to bed and awakenings by ignoring demands for attention. The child is placed in its bed and ignored pending sleep onset.
- Graded extinction
follows the same principle as extinction, but involves the gradual withdrawal of parental attention. It may be recommended that parents respond to the child's cries at lengthening intervals to teach the child to soothe itself to sleep. For example, parents may initially respond to cries after 2 minutes, then on the next occasion after 4 minutes and so on to a maximum of 20 minutes. Alternatively, parents may gradually increase the physical distance between themselves and the child. For example, the parent may start off sitting next to the child's bed, then on the second night move 30 cm away and so on until the parent is outside the child's room.
- 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.
- Parasomnias
are undesirable phenomena (physical or behavioural events) that occur predominantly during sleep. They can include nightmares, sleep terror disorder, and sleepwalking.
- Scheduled waking
is based on the rationale that by systematically waking the child before they usually awake the likelihood of spontaneous awakenings is reduced. The frequency of the scheduled wakes is gradually reduced and eventually discontinued.
- Sleep hygiene
, also referred to as positive routines, is an umbrella term for several modifications to the environment, and to behaviour that parents would perform in order to prepare their child for sleep in a more effective way. Examples include: removing caffeine from the child's diet, a short regular routine leading up to bed, ensuring the bedroom environment is conducive to sleep (dark, quiet, comfortable, no extreme temperatures), and avoiding boisterous play immediately before bedtime.
- Sleep latency
is the time between going to bed and going to sleep.
- Sleep restriction
is intended to increase the sleep efficiency of the child (the ratio of total sleep time to time spent in bed). The child is only allowed in bed when sleeping and the time allowed in bed is gradually increased. This increases the association of being asleep and being in bed.
- Very low-quality evidence
Any estimate of effect is very uncertain.
Insomnia in the elderly
Nocturnal enuresis
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
Oliveiero Bruni, Sapienza University, Rome, Italy.
Luana Novelli, Sapienza University, Rome, Italy.
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