Sleep for Stroke Management and Recovery Trial (Sleep SMART): Rationale and methods

Abstract

Rationale Obstructive sleep apnea is common among patients with acute ischemic stroke and is associated with reduced functional recovery and an increased risk for recurrent vascular events. Aims and/or hypothesis The Sleep for Stroke Management and Recovery Trial (Sleep SMART) aims to determine whether automatically adjusting continuous positive airway pressure (aCPAP) treatment for obstructive sleep apnea improves clinical outcomes after acute ischemic stroke or high-risk transient ischemic attack. Sample size estimate A total of 3062 randomized subjects for the prevention of recurrent serious vascular events, and among these, 1362 stroke survivors for the recovery outcome. Methods and design Sleep SMART is a phase III, multicenter, prospective randomized, open, blinded outcome event assessed controlled trial. Adults with recent acute ischemic stroke/transient ischemic attack and no contraindication to aCPAP are screened for obstructive sleep apnea with a portable sleep apnea test. Subjects with confirmed obstructive sleep apnea but without predominant central sleep apnea proceed to a run-in night of aCPAP. Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months. Telemedicine is used to monitor and facilitate aCPAP adherence remotely. Study outcomes Two separate primary outcomes: (1) the composite of recurrent acute ischemic stroke, acute coronary syndrome, and all-cause mortality (prevention) and (2) the modified Rankin scale scores (recovery) at six- and three-month post-randomization, respectively. Discussion Sleep SMART represents the first large trial to test whether aCPAP for obstructive sleep apnea after stroke/transient ischemic attack reduces recurrent vascular events or death, and improves functional recovery.

Positive Airway Pressure Therapy in Sleep-Disordered Breathing

“…Primary outcomes will include recurrence of ischemic stroke, ischemic coronary events, all-cause mortality, and standardized recovery scores. Overall, this is a promising study and the results will hopefully add to our knowledge of the interplay between OSA and neurologic outcomes [38].…”

Questionnaire and Portable Sleep Test Screening of Sleep Disordered Breathing in Acute Stroke and TIA

“…While no inpatient test has sufficient sensitivity to obviate the need for a PSG in the acute stroke population, PST has been shown in our study and in others to be highly consistent with PSG and can expedite the diagnosis of SDB [20]. We outline our proposed algorithm for SDB screening in acute stroke in Figure 2 [21].…”

Sleep and Stroke: Opening Our Eyes to Current Knowledge of a Key Relationship

“…Such uncertainty of efficacy of SA treatment in poststroke patients is reflected by diverging recommendations coming from European guidelines [13 ••] that endorse to screen and treat SA in post-stroke patients and American Heart Association guidelines [81••] that does not propose this approach, suggesting to enroll patients in clinical trials. Ongoing trials [82,83] evaluating the effect of early treatment of SDB with different nocturnal ventilatory supports in acute stroke on outcome will hopefully clarify the feasibility and efficacy of such treatment in acute stroke.…”