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. 2019 May 1;2019(5):CD010990. doi: 10.1002/14651858.CD010990.pub2

Van Maanen 2012.

Methods Randomised cross‐over trial
Participants POSA
Participants randomised: 30
Inclusion criteria
  • Age > 18 years

  • Referred to the Department of Otorhinolaryngology, Head and Neck Surgery of the Saint Lucas Andreas Hospital (Amsterdam, Netherlands)

  • Diagnosed with positional sleep apnoea, using full overnight in‐hospital polysomnography defined as AHI > 5, AHI supine ≥ 2 times AHI in other positions, percentage of total sleep time in supine position ≥ 10 and ≤ 90%


Exclusion criteria: no exclusion criteria given
Interventions Vibrating device worn on the back of neck that senses supine position in the on and off position, on randomly assigned nights within 3 months of each other
Outcomes
  • AHI

  • Supine AHI

  • Non‐supine AHI

  • Total supine sleep time

  • Sleep efficiency

  • SaO2 sleep efficiency

  • Arousal index

Notes Settings: outpatient ENT services, Saint Lucas Andreas Hospital, Netherlands
 Duration of follow‐up: 3 sleep studies over 3‐month period
Adherence: overnight PSG studies in hospital, in 3 however device malfunctioned in 'on state'
 Drop out: nil
 Funding: Not mentioned
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study authors have not stated the randomisation procedure in clear terms. There was a mere mention that the device was put on or off 'randomly'. We tried to contact the study author for clarification, but were unsuccessful
Allocation concealment (selection bias) Unclear risk The methods are not properly stated
Blinding of participants and personnel (performance bias) 
 Objective outcomes ( AHI) Unclear risk Device worn on both nights, however due to nature of intervention participants cannot be blinded, but all reported outcomes are objective
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "The data were reviewed manually for analysis by an experienced sleep investigator, blinded for the activity state of the device" page 323.
Comment: outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No attrition
Selective reporting (reporting bias) Unclear risk As no specific outcomes or comparisons were listed a priori, difficult to ascertain whether the listed outcomes are those planned or not
Other bias Unclear risk Statistically analysis is probably not appropriate. They have 3 group comparison, but used t‐tests individually. They have conceded that the distributions were not normal, and sometimes Wilcoxon rank sum test would be used. But it is not clear how and where it was used. It is also not clear whether paired t‐test was used

AHI: Apnoea‐Hypopnoea Index; BMI: body mass index; CPAP: continuous positive airway pressure; ESS: Epworth Sleepiness Scale; FOSQ: Functional Outcome of Sleep Questionnaire; MOS: Medical Outcome Study; OSA: obstructive sleep apnoea; POSA: positional obstructive sleep apnoea; PSG: polysomnography; REM: rapid eye movement; SaO2: oxygen saturation; SD: standard deviation; SOSQ: Symptoms of Sleep Questionairre; SF‐36: Short Form Health Survey; SPT: sleep position trainer; WHO MONICA: World Health Organization Monitoring Trends and Determinants in Cardiovascular Disease