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StrokeNet SleepSmart: Sleep for Stroke Management and Recovery Trial

This research is being done to figure out whether treatment for sleep apnea, in people who have had a stroke or TIA, improves recovery from stroke, and helps prevent future stroke, heart problems, and death. The intervention being tested is called continuous positive airway pressure (CPAP). The U.S. Food and Drug Administration (FDA) has approved CPAP for the treatment of obstructive sleep apnea. Sleep apnea is a disorder in which breathing stops or nearly stops repeatedly while you sleep. This condition affects most (about 75 out of 100) stroke and TIA patients. Sleep apnea occurs when the throat narrows or closes off, repeatedly, during sleep. This causes you to stop breathing, or take breaths that are too small, because airflow is blocked. This can happen many times per hour, while you sleep. Each time, your body’s oxygen levels can decrease, and your brain may wake you up – though too briefly for you to remember it – so that you can breathe again. Even though the effects on the brain and body can be dramatic, people often don’t realize that they have sleep apnea. In stroke and TIA patients especially, sleep apnea often goes unnoticed because the typical symptoms, snoring and daytime sleepiness, may not occur. People with sleep apnea may have worse outcomes after stroke. We think CPAP treatment may improve outcomes after stroke. However, we do not know if CPAP treatment has a good or bad effect on stroke recovery or stroke prevention.   

 A total of 15,010 patients are expected to enroll in this study and be screened for sleep apnea across about 110-150 sites in the United States. About 3,000 are expected to participate in the second part of the study, in which sleep apnea treatment is tested.  

Status
Open and enrolling subjects.
Location
Phoenix, Arizona
Total Participants
15010
Primary Sponsor
University of Michigan
Additional Sponsor(s)
National Institute of Neurological Disorders and Stroke (NINDS)
FusionHealth LLC
Medical University of South Carolina
University of Cincinnati

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