A surgically implanted upper airway stimulation device led to significant improvement in a majority of patients with obstructive sleep apnea in a national clinical trial. The findings are published in the New England Journal of Medicine http://www.nejm.org. B. Tucker Woodson, MD, professor of otolaryngology and communication sciences and chief of sleep medicine at Froedtert & the Medical College of Wisconsin, is the co-primary investigator of the multi-center study.
Obstructive sleep apnea (OSA) impacts 18 million Americans, and it is estimated that up to half of sufferers go undiagnosed. Patients stop breathing frequently during sleep, often for a minute or longer. If untreated, OSA can lead to heart disease, hypertension and stroke. A continuous positive airway pressure device, or CPAP, is the most common treatment for OSA, but some patients cannot tolerate CPAP.
In this study, researchers investigated a new therapy called the Inspire Upper Airway Stimulation Device. The device is surgically implanted and delivers mild stimulation to the hypoglossal nerve to prevent airway obstruction during sleep. 126 participants, 83 percent of them male, participated in the 12-month study. The device was shown to reduce the episodes of hypopnea (shallow breathing or low respiratory rate) by up to 70 percent, and patients had significantly fewer episodes of oxygen desaturation. Patients also reported less sleepiness, and a higher quality of life.
Patrick J. Strollo, Jr., MD, professor of medicine and clinical and translational science at the University of Pittsburgh and medical director of the University of Pittsburgh Medical Center Sleep Center, is the lead author of the paper.
The study was funded by Inspire Medical Systems.
Co-investigators include researchers from University Hospital, Mannheim; Intersom K.ln, Cologne; Sint Lucas Hospital, Amsterdam; North Memorial Sleep Health Center, Maple Grove; Paparella Ear, Head, and Neck Institute; St. Cloud Ear, Nose, and Throat; the University of South Florida College of Medicine; the St. Petersburg Sleep Disorders Center; the University of Cincinnati; the Medical College of South Carolina, Charleston; Antwerp University Hospital; the University of Antwerp; the Borgess Medical Center; the Louis Stokes Cleveland Veterans Affairs Medical Center; and, Case Western Reserve University.
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