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Publication in SLEEP Journal Demonstrates Positive Results of Large Multi-Center Clinical Trial for Provent® Sleep Apnea Therapy
Date:4/4/2011

BELMONT, Calif., April 4, 2011 /PRNewswire/ -- Ventus Medical, Inc. today reported positive results from a 19 center clinical trial using its FDA-cleared Provent® Sleep Apnea Therapy device to treat obstructive sleep apnea. Provent Therapy uses the patient's own breathing to create expiratory positive airway pressure (EPAP) to keep the airway open during sleep. The full results of this three month study were published in the April 2011 issue of the peer-reviewed medical journal SLEEP, an official publication of the American Academy of Sleep Medicine.

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"This randomized, sham-controlled study demonstrates that Provent Therapy significantly improves the apnea hypopnea index (AHI), a scale to measure the number of breathing interruptions or stoppages per hour of sleep, as well as subjective sleepiness, as measured by the Epworth Sleepiness Scale (ESS) in patients with obstructive sleep apnea," said study author Richard B. Berry, M.D., professor of medicine at the University of Florida College of Medicine, medical director of the University of Florida and Shands Sleep Disorders Center, and former president of the American Sleep Medicine Foundation. "Importantly, self-reported patient adherence on Provent Therapy was almost 90 percent."

The prospective, double-blind, sham-controlled clinical study enrolled 250 patients diagnosed with obstructive sleep apnea at 19 academic and private sleep centers in the United States.  The primary endpoint of the study was the reduction in AHI.  In-laboratory polysomnography, a method of monitoring breathing disruptions during sleep, was performed at the start of the study and after three months of treatment.

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