EPAP Therapy Found to Be Effective Alternative to CPAP

June 23, 2010
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Results from two clinical trials add to the evidence that Ventus Medical’s Provent® Sleep Apnea Therapy device, which utilizes nasal expiratory positive airway pressure (EPAP), is effective for the treatment of mild, moderate, and severe obstructive sleep apnea (OSA). The findings were presented at SLEEP 2010, the 24th annual meeting of the Associated Professional Sleep Societies held in San Antonio June 5-9.

One of the trials was conducted at the Sleep Medicine and Research Center at St. Luke’s Hospital in St. Louis and included patients who had previously refused continuous positive airway pressure (CPAP) therapy or who had used CPAP fewer than 3 hours per night on average. Of 59 patients who met inclusion criteria, 47 (80%) tolerated the device. Of those patients, 56% (41% of all patients) met efficacy criteria, which included statistically significant decreases in the apnea-hypopnea index (AHI).
Researchers reported that Provent also improved oxygen saturation and resulted in less daytime sleepiness as measured by the Epworth Sleepiness Scale. Self-reported adherence to therapy with the device was approximately 92% of sleep time.
The second trial, utilizing a multicenter, randomized, controlled design, included 250 patients who had not previously used a CPAP device and who had an AHI of less than 10. They were randomized to treatment either with Provent EPAP therapy (n = 127) or a placebo device (n = 123).
Seventy-seven patients in the EPAP group and 67 in the placebo group completed the 3-month trial. Results from this trial also showed that Provent therapy significantly reduced AHI, improved oxygen saturation, and reduced daytime sleepiness.
Richard Berry, MD, from the University of Florida, one of the researchers for the multicenter trial, stated, “The results of the study suggest that Provent therapy is an effective treatment alternative for a substantial percentage of OSA patients.”
The Provent device, which is available by prescription, uses a valve design. The device is placed over the nostrils and secured with hypoallergenic adhesive. During inhalation, the valve opens, allowing nearly unobstructed airflow, and during exhalation, the valve closes, directing airflow through two small openings, thus increasing expiratory airway pressure.