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. 2015 Jul 2;2015(7):CD007030. doi: 10.1002/14651858.CD007030.pub3

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
Interventions Treatment intervention: active CPAP
Control intervention: sham CPAP
Treatment duration: 3 months
Delivered by: voluntary use by participants
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
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
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