Van Maanen 2012.
Methods | Randomised cross‐over trial | |
Participants | POSA Participants randomised: 30 Inclusion criteria
Exclusion criteria: no exclusion criteria given |
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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 |
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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 |
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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