Obstructive sleep apnea (OSA) is one of the most common sleep disorders in adults.
It’s also frequently observed in patients with one of the most common debilitating and sometimes fatal disorders, acute ischemic stroke. For decades, stroke researchers and clinicians have noted a clear association between OSA and the occurrence of stroke and transient ischemic attacks (TIAs). The current theory is that, if left untreated, OSA is associated with a poor recovery from stroke and an increased risk for another stroke.
While many observational studies have demonstrated a potential cause-and-effect relationship between OSA and stroke, and a few have even illustrated the health and recovery benefits of OSA treatment, there haven’t been any large-scale, randomized studies designed to specifically evaluate the effects of OSA treatment in patients with stroke and/or TIA — until now.
The Sleep for Stroke Management and Recovery Trial (Sleep SMART) was launched to determine whether treating OSA immediately after an acute ischemic stroke or TIA using continuous positive airway pressure (CPAP) improves stroke/TIA recovery and/or reduces the recurrence of stroke and cardiovascular events. Sleep SMART was initiated by researchers at the University of Michigan in collaboration with the National Institute of Neurological Disorders and Stroke (NINDS) StrokeNet to recruit subjects from across the US. In addition, Nox Health was chosen to oversee all tele-sleep diagnostic testing, OSA treatment with CPAP, and technology-enabled medical and behavioral therapy support.
The purpose of the study is twofold; to determine whether treating OSA shortly after acute ischemic stroke or TIA:
- Reduces the recurrence of stroke, acute coronary syndrome and all-cause mortality during the first six months of recovery, and
- improves stroke-related functional outcomes in the first six months of recovery.
In 2019, the Sleep SMART team was awarded $45M, the largest National Institutes of Health (NIH) grant ever allocated to study OSA treatment and stroke. Currently, the study is in the process of enrolling more than 3,000 subjects from 110 clinical research sites over a five-year period.
As the principal telemedicine investigators for Sleep SMART, the Nox Health Clinical Science and Applied Analytics team is forging new ground in the care of acute ischemic stroke. By applying our clinical science approach to OSA, along with years of expertise in tele-sleep diagnostics, treatment and medical and behavioral management, the team looks forward to demonstrating the potential impact of our innovative sleep health care for those who have experienced, or who are at risk for, ischemic stroke.
A publication detailing the study methods, expected analyses and outcomes was released in the International Journal of Stroke [Brown DL et al., Sleep for Stroke Management and Recovery Trial (Sleep SMART): Rationale and methods. Int J Stroke, 2020;15(8):923-9].
Learn more about the Sleep SMART trial here.
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