Sleep for Stroke Management And Recovery Trial (Sleep SMART)

Treatment of obstructive sleep apnea (OSA) for stroke prevention and recovery represents a rare chance to
achieve transformative impact on post-stroke care and outcomes. OSA is highly prevalent after stroke (~75%)
and is a known risk factor for poor functional outcome, mortality, and recurrent stroke. Furthermore, OSA is
readily treated by a safe, simple, and relatively low-cost therapy, continuous positive airway pressure (CPAP).
Observational studies have already demonstrated better stroke outcomes among patients who use CPAP, and
multiple pilot trials have hinted at the benefits of CPAP after stroke. These studies have laid the foundation for
a definitive trial on the role of CPAP in post-stroke management. The pressing need for this critical next step is
highlighted in the latest American Stroke Association secondary stroke prevention guidelines. Therefore, the
investigators now propose a phase III, open-label, blinded-endpoint assessment, multicenter, randomized,
controlled trial to determine (1) whether treatment of OSA with CPAP after acute ischemic stroke or high-risk
transient ischemic attack (TIA) helps to prevent recurrent stroke, acute coronary syndrome, and all-cause
mortality 6 months after the event, and (2) whether treatment of OSA shortly after acute ischemic stroke
improves stroke outcomes at 3 months. This study capitalizes on an efficient and cost-saving design involving
a 6-month prevention trial with an embedded 3-month recovery trial. Many years of pilot work have identified
the challenges related to the diagnosis and treatment of OSA after stroke. These valuable insights - combined
with innovative digital and biomedical technology - have contributed to this highly pragmatic trial in which
feasibility is paramount. In particular, as polysomnography and CPAP titration are seldom tolerated just after
acute stroke, OSA will be identified through use of a portable cardiopulmonary sleep apnea test, and treated
with an automatically adjusting CPAP device. Through state-of-the-art methods, subjects will receive
centralized, real-time, nightly monitoring of CPAP use and proactive care management to maximize CPAP
adherence. This approach simplifies and streamlines the diagnosis and treatment of OSA, which will facilitate
implementation in hospitals with low resources. Consequently, this trial provides StrokeNet with an opportunity
to use its network more fully, and will permit positive trial results to be readily translated into community
settings across the U.S. This study represents a rare opportunity to change post-stroke care in a fundamental
manner with a safe, cost-effective intervention that could improve both recovery and prevention in a substantial
proportion of patients.

Grant Number: 5U01NS099043-04
NIH Institute/Center: NIH
Principal Investigator: DEVIN BROWN