Brown 2013.
Methods | Parallel randomised trial Method of randomisation: randomised stated, method unclear Method of concealment: used sham control with device of identical appearance of that for active CPAP Blinding: double‐blind Analysis: only reported data of participants who had completed the 3‐month follow‐up (available‐case analysis) | |
Participants | Location: USA
Setting: enrolled from a single centre of inpatient neurology service, the treatment was conducted in the community
Number of participants: 32 at randomisation (59% male, median unknown), 19 completed study, case‐available analysis for 19 participants Treatment group: 15 (33% male, median age 61 years, IQR 46 to 76) Control group: 17 (76% male, median age 74 years, IQR 55 to 81) Stroke criteria: ischaemic stroke based on accepted clinical criteria Time since stroke onset at randomisation: median time from stroke onset to CPAP titration was 4 days Fatigue criteria: participants did not have to have fatigue to be recruited Other entry criteria: had sleep apnoea; modified Rankin Scale ≥ 2 Comparability of groups: unclear |
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Interventions | Treatment intervention: active CPAP Control intervention: sham CPAP Treatment duration: 3 months Delivered by: voluntary use by participants |
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Outcomes | Time for fatigue assessment: by the end of 3‐month use of CPAP Primary outcome: objective usage data of CPAP Secondary outcome: FSS score |
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Notes | Only people with sleep apnoea were recruited This study was primarily aimed at testing the feasibility of CPAP to treat sleep apnoea in people with stroke. Fatigue was measured as 1 of the symptoms of sleep apnoea for the efficacy of CPAP The investigators reported median scores and IQR of FSS and we requested mean scores and SD from the investigators Funding: National Institutes of Health Grant K23 NS051202 and National Center for Research Resources Grant M01‐RR000042 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Quote: "The active and sham CPAP units were identical in appearance, with the exception of the barely discernible augmented leak port on the latter, and made similar sounds while on"; "blinding to subject condition was successfully maintained" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Outcome assessors were masked to intervention allocation" |
Intention‐to‐treat | High risk | Available‐case analysis: only reported data of participants who had completed the 3‐month follow‐up |