A multilevel CPAP support strategy implemented within a large stroke clinical trial (sleep SMART).

Brown DL, Durmer JS, Aloia M, Hankla RM, Novitski K, Sickler JB, Considine S, Delacroix E, Ong JC, Baran AS, Anderson CS, Bravata DM, Yaggi HK, Durkalski-Mauldin V, Chervin RD. A multilevel CPAP support strategy implemented within a large stroke clinical trial (sleep SMART). Frontiers in sleep. 2026 May 25; 5:1832143, DOI: 10.3389/frsle.2026.1832143.

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Abstract:

INTRODUCTION: Continuous positive airway pressure (CPAP) clinical trials require integrated CPAP support programs, especially in challenging patient populations. Herein, we describe the CPAP support program devised and implemented within the largest CPAP trial to date in patients with recent acute stroke, the Sleep for Stroke Management and Recovery Trial (Sleep SMART). METHODS: We developed a comprehensive, primarily remote, multi-level and -component automatically-adjusting CPAP (APAP) use support strategy for application across diverse enrollment sites with varied resources. Although many components were pre-planned, some were developed during the conduct of the trial, reflecting innovation and adaption to new technologies. Sites received training and guidance on APAP during the inpatient setting, and a robust telemedicine-based support program was implemented to maximize participant convenience and access. The APAP support program included patient-level behavioral and educational strategies, technical support, objective monitoring and feedback, social support, and system-level facilitation to address the complex determinants of APAP use. RESULTS: Among the 146 sites across the United States, 138 enrolled at least one participant, and 129 sites randomized at least one participant. Overall, 1,892 participants were equally randomized (1:1) between the two treatment arms from 2019 to 2025, and outcome assessments are ongoing. DISCUSSION: In this large multicenter clinical trial of APAP in stroke patients, a range of APAP support components were implemented at site- and participant-levels. A comprehensive and standardized APAP support program can be delivered, using a combination of centralized and non-centralized tools, without reliance on local sleep medicine expertise for a clinically complex and difficult-to-treat population. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, identifier NCT03812653.