Study Objectives:Investigate the efficacy of a novel nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).

Design:A prospective, multicenter, sham-controlled, parallel-group, randomized, double-blind clinical trial.

Setting:19 sites including both academic and private sleep disorder centers

Patients:Obstructive sleep apnea with a pre-study AHI ≥ 10/hour

Interventions:Treatment with a nasal EPAP device (N = 127) or similar appearing sham device (N = 123) for 3 months. Polysomnography (PSG) was performed on 2 non-consecutive nights (random order: device-on, device-off) at week 1 and after 3 months of treatment. Analysis of an intention to treat group (ITT) (patients completing week 1 PSGs) (EPAP N = 119, sham N = 110) was performed.

Measurements and Results:At week 1, the median AHI value (device-on versus device-off) was significantly lower with EPAP (5.0 versus 13.8 events/h, P < 0.0001) but not sham (11.6 versus 11.1 events/h, P = NS); the decrease in the AHI (median) was greater (−52.7% vs. −7.3%, P < 0.0001) for the ITT group. At month 3, the percentage decrease in the AHI was 42.7% (EPAP) and 10.1% (sham), P < 0.0001. Over 3 months of EPAP treatment the Epworth Sleepiness Scale decreased (9.9 ± 4.7 to 7.2 ± 4.2, P < 0.0001), and the median percentage of reported nights used (entire night) was 88.2%.

Conclusions:The nasal EPAP device significantly reduced the AHI and improved subjective daytime sleepiness compared to the sham treatment in patients with mild to severe OSA with excellent adherence.

Clinical Trial Information:Registrations: ClinicalTrials.gov. Trial name: Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea (AERO). URL: http://www.clinicaltrials.gov/ct2/show/NCT00772044?term=Ventus&rank=1. Registration Number: NCT00772044.

Citation:Berry RB; Kryger MH; Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. SLEEP 2011;34(4):479-485.

 
BELMONT, Calif., Oct. 17, 2011 /PRNewswire/ -- Ventus Medical today announced that the results of a large, long-term study of its proprietary Provent® Sleep Apnea Therapy, an innovative, non-invasive treatment for obstructive sleep apnea (OSA), were published in the November 2011 issue of the Journal of Clinical Sleep Medicine, an official publication of the American Academy of Sleep Medicine.

"This study provides further validation that Provent Therapy is an effective treatment for some OSA patients as it reduces daytime sleepiness, apnea hypopnea index (AHI) and snoring associated with this prevalent condition," said Meir Kryger, M.D., of Gaylord Sleep Medicine and past president of the American Academy of Sleep Medicine. "Patients reported wearing the device almost 90 percent of the nights, which represents very high compliance. The current gold standard, continuous positive airway pressure (CPAP) is very effective but many patients do not use it adequately. Provent represents an important new treatment option for many obstructive sleep apnea patients."

About the Study

The 13-center, 12-month study was an extension of the 3 month study that was previously published in the Journal SLEEP. Patients who were compliant with the device and demonstrated adequate treatment were enrolled for this extension study.  These patients showed a 70 percent reduction in the median AHI after 12 months of treatment with Provent Therapy.  AHI is a measure of number of breathing pauses per hour of sleep. In addition, the study confirmed a very high nightly compliance rate of 89 percent. Epworth Sleepiness Scale (a measure of sleepiness) was reduced five points and snoring was reduced by 74 percent. The publication of the data can be found at: http://www.aasmnet.org/jcsm/currentissue.aspx.

"As we expand our footprint in the United States and international markets, we believe it is critically important to have solid peer-reviewed, high quality research like this study to validate the benefits of using Provent Therapy to treat OSA," said Peter Wyles, President and Chief Executive Officer of Ventus Medical. "We commend Dr. Kryger and his colleagues on the results of this important long-term study."

About Provent® Sleep Apnea Therapy

Provent is a proprietary medical device used for the treatment of obstructive sleep apnea (OSA). The device has been shown to be clinically effective in a series of peer-reviewed studies.  It is an easy to use, non-invasive and disposable treatment that works across mild, moderate, and severe OSA. Provent Therapy utilizes nasal expiratory positive airway pressure (EPAP) to keep a patient's airway open during sleep and has been clinically proven in numerous studies to reduce sleep apnea.  It incorporates a novel MicroValve design that is placed over the nostrils and secured with hypoallergenic adhesive. During inhalation, the valve opens allowing nearly unobstructed airflow. During exhalation, the valve closes, limiting airflow through small openings, which increases expiratory pressure and keeps the airway open, preventing disruption in breathing. Provent® Therapy is accepted onto the Australian Register of Therapeutic Goods (ARTG), is FDA cleared and has CE marking. For more information, please visit www.proventtherapy.com.

About Ventus Medical

Ventus Medical is a privately-held medical device company dedicated to providing non-invasive medical solutions for people with sleep-disordered breathing. Based on its innovative MicroValve technology and patented designs, Ventus has developed a unique line of clinically-proven medical devices to address the continuum of sleep disorders from severe obstructive sleep apnea (OSA) to mild snoring. Ventus Medical devices work by creating expiratory positive airway pressure (EPAP). The company markets Provent® Therapy, a discreet, easy-to-use nasal device, for the treatment of obstructive sleep apnea in the United States, Australia, Hong Kong and India, and is developing an over-the-counter device for snoring. www.ventusmedical.com.

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