Jackson 2015.
Methods | Randomised controlled parallel‐arm trial | |
Participants | POSA Participants randomised: 86 Inclusion criteria
Exclusion criteria
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Interventions | A 10‐point sleep guide to improve OSA with and without sleep position modification device. The sleep position modification device consisted of a band of stretch cotton worn around the chest, just below the nipple line and with straps over the shoulder to hold it in place. The band was secured at the front with buttons and the ball was contained in a pocket at the rear, over the thoracic spine. |
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Outcomes | Outcomes: supine sleep time, total sleep time, AHI, supine AHI, sleep efficiency, arousal index, BMI, blood pressure, ESS and quality‐of‐life scales e.g. FOSQ, SOSQ, and neuropsychological test battery like psychomotor vigilance test, response inhibition test, Trail Making Task A and B, digit symbol substitution task, digits span test and controlled word association task | |
Notes | Setting: outpatient department Austin Health, USA
Duration of treatment: 4 weeks Adherence not assessed Funding: likely mixed funding "This work was supported by grants from the Institute for Breathing and Sleep, the Austin Health Medical Research Foundation and the Harold and Cora Brennen Benevolent Trust" Confict of interest declared: Dr Howard has received funding from ResMed foundation, Edansafe and Prevention Express |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "A randomisation sequence at a 1:1 active:control ratio was computer generated by a third party and the investigators were provided with sealed envelopes", page 547 Comment: 1:1 allocation was planned, but numbers in the arms are very dissimilar (37 and 49) |
Allocation concealment (selection bias) | Low risk | Quote: "A randomisation sequence at a 1:1 active:control ratio was computer generated by a third party and the investigators were provided with sealed envelopes. These were opened in order of enrolment", page 547 Comment: computer‐generated randomisation sequence was provided by a third party in sealed envelopes to be opened in the order of enrolment |
Blinding of participants and personnel (performance bias) Objective outcomes ( AHI) | High risk | Not possible due to the nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Primary outcome for which sample size was calculated is not reported explicitly |
Other bias | Unclear risk | It is not clear whether the study adjusted for multiple comparisons. |