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
Exclusion criteria
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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 |