Original Article
Sleep Apnea Treatment After Stroke (SATS) Trial: Is It Feasible?

https://doi.org/10.1016/j.jstrokecerebrovasdis.2011.06.010Get rights and content

Sleep apnea affects more than half of patients with acute ischemic stroke and is associated with poor stroke outcome. This pilot study assessed the feasibility of a randomized, sham-controlled continuous positive airway pressure (CPAP) trial in subjects with acute ischemic stroke. Subjects identified with sleep apnea based on an apnea-hypopnea index ≥5 on overnight polysomnography or portable respiratory monitoring within 7 days of onset of stroke symptoms were randomized to receive active or sham CPAP for a 3-month period. Objective usage was ascertained by compliance data cards. Subjects, treating physicians, and outcome assessors were masked to intervention allocation. Among 87 subjects who provided consent, 74 were able to complete sleep apnea screening, 54 (73%) of whom had sleep apnea. Thirty-two subjects agreed to randomization. Of the 15 subjects who commenced active titration, 11 (73%) took the device home, and 8 (53%) completed the 3-month follow-up. Of the 17 subjects who commenced sham titration, 11 (65%) took the sham device home and completed the 3-month follow-up. The median cumulative usage hours over the 90 days were similar in the active group (53 hours; interquartile range, 22-173 hours) and the sham group (74 hours; interquartile range, 17-94 hours), and blinding to subject condition was successfully maintained. This first-ever randomized, sham-controlled trial of CPAP in patients with recent stroke and sleep apnea demonstrates that sham treatment can be an effective placebo.

Section snippets

Study Design

The Sleep Apnea Treatment After Stroke (SATS) Trial was a single-center pilot, prospective, randomized, sham-controlled trial of CPAP in stroke patients in which subjects, treating physicians, and outcome assessors were masked to intervention allocation. Subjects were enrolled between September 2004 and March 2010 from the inpatient neurology service at the University of Michigan. Adult subjects were eligible if they had sustained an ischemic stroke, based on accepted clinical criteria,10

Results

Out of 87 subjects, 74 completed sleep apnea screening (Fig 1). Four of the 40 subjects who initiated polysomnography (10%) could not tolerate the procedure and abandoned the study during the night. Only 1 subject had an AHI ≥5 with more central apneic episodes than obstructive apneic episodes. Twenty-four of the 40 (60%) had obstructive sleep apnea (OSA), defined as an AHI of ≥5 with more obstructive than central apneic episodes. Five subjects were excluded off protocol. In 1 of these

Discussion

This first-ever randomized, sham-controlled trial of CPAP in patients with recent stroke and sleep apnea shows that sham CPAP can be an effective placebo even during the challenging immediate aftermath of ischemic stroke. In this trial, sham CPAP was at least as tolerable and believable as active CPAP. However, this rigorously designed and documented pilot randomized controlled trial also highlights challenges that need to be addressed to ensure the success of a full-scale, definitive trial.

Acknowledgment

Special thanks to Karen C. Johnston, MD, MSc, Medical Monitor.

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    Supported by National Institutes of Health Grant K23 NS051202 and National Center for Research Resources Grant M01-RR000042. The contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health or the National Center for Research Resources. Respironics Inc (now Philips) and Puritan Bennett (now Covidian) provided material support but had no role in the study design, analysis, or manuscript preparation.

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