Ann Arbor’s U-M, Atlanta’s FusionHealth Collaborate in $45M Clinical Trial to Study Sleep Apnea, Stroke
U-M and FusionHealth are working on a clinical trial to better define the relationship between sleep apnea and stroke.
The University of Michigan in Ann Arbor and FusionHealth in Atlanta today announced a collaborative $45-million clinical trial during which researchers will investigate whether obstructive sleep apnea diagnosis and treatment improves stroke recovery or reduces the likelihood of another stroke.
There has long been a recognized association between stroke and sleep apnea, but experts don’t know whether many patients’ sleep apnea was always there and may have led to stroke, whether the sleep apnea was exacerbated or created due to the stroke, or a combination of the two scenarios.
“Not only do the majority of post-stroke patients suffer from sleep apnea, but they are also often at a heightened risk of another stroke,” says Dr. Jeffrey Durmer, sleep expert and co-founder of FusionHealth. “The results of this study could be revolutionary in providing both preventative and recovery care to patients following a stroke.”
Researchers at 110 sites through the National Institutes of Health-funded StrokeNet clinical trial network plan to enroll 3,000 post-stroke patients in a randomized, controlled trial. Patients will begin the trial while still in the hospitals, so the treatment group can begin right away.
The study will compare the standard treatment for sleep apnea – continuous positive airway pressure (CPAP) – with standard care after stroke. At three and six months after random assignment to one approach or the other, the investigators will compare the treatment group’s stroke-related outcomes with those of the control group. The aim is to determine whether going forward, future patients who have a stroke should be screened and treated for obstructive sleep apnea.
FusionHealth will supply the sites with sleep apnea testing and CPAP equipment, incorporating telemedicine to better monitor patient adherence and results without requiring overnight sleep apnea tests or constant clinic visits.
Funding for the trial comes from the National Institute of Neurological Disorders and Stroke at the National Institutes of Health. The researchers are working closely with NIH StrokeNet centers at the Medical University of South Carolina, which provides the national data management center, and the University of Cincinnati, which serves as the national coordinating center.
FusionHealth is a sleep-health technology company that provides employers and health-care systems with population-based solutions to address sleep issues.