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

Bignold 2011.

Methods Randomised controlled cross‐over trial
Participants POSA
Participants randomised: 16
Gender: male:13; female: 2
Age (years): 58.2 ± 13.9
Inclusion criteria
People with POSA
  • Overall AHI ≥ 15

  • Supine AHI twice the non‐supine AHI

  • ≥ 20 min or more of sleep in supine and non‐supine postures

  • Non‐supine AHI < 15


Exclusion criteria
  • Exclusion criteria for existing treatments for OSA (e.g. ventilator requirement)

  • Mobility‐limiting problems inhibiting lateral sleep

  • Cardiac pacemaker use

Interventions Intervention: positional monitoring and supine alarm device in active mode
 Control: device in inactive mode
Outcomes AHI, snoring loudness, percentage of time in supine posture
Notes Setting: home‐based regimen
 Duration of treatment: 7 days; 1 week active vibration and 1 week inactive vibration in random order, separated by an intervening washout week
 No period effect as demonstrated using linear mixed‐model analysis with an auto regressive covariance structure (using supine time data among participants ‐ i.e. the control phase data)
 Funding: Flinders Medical Centre foundation grant; not industry sponsored
 Comment: study results are applicable only to POSA.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The procedure for randomisation is not mentioned. High risk may be mitigated by the cross‐over design of the study.
Allocation concealment (selection bias) Unclear risk Allocation concealment not explicitly stated. The contribution of allocation concealment to the risk of bias is low by virtue of the design of the study
Blinding of participants and personnel (performance bias) 
 Objective outcomes ( AHI) High risk Quote: "It is difficult to blind patients to active versus inactive treatment" (Protocol first paragraph page 378)
Comment: likely unblinded. Participant blinding not possible
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding not mentioned
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No attrition
Selective reporting (reporting bias) Unclear risk Unclear, as we could not access the protocol of the study
Other bias Low risk None identified