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.

 
Large corporations could save millions of dollars in lost productivity by screening and treating high-risk employees for obstructive sleep apnea, suggests a research abstract that will be presented Monday, June 13, in Minneapolis, Minn., at SLEEP 2011, the 25th Anniversary Meeting of the Associated Professional Sleep Societies LLC (APSS).

Results show that a large corporation in Florida could save an estimated $136 million in lost productivity over 10 years by screening high-risk employees for OSA and offering treatment with continuous positive airway pressure (CPAP) therapy. The study found that 608 employees of the corporation were middle-aged, obese men who were at high risk for OSA.

According to the authors, untreated OSA results in job performance deficiencies such as excessive sleepiness, cognitive dysfunction, irritability and reduced vitality. Research shows that work performance can be decreased by 30 percent due to sleep fragmentation and repetitive hypoxia, which are characteristics of OSA.

"This cost-benefit analysis proposed OSA screening and treatment for high-level management professionals who had high salaries," said principal investigator Dr. Clelia Lima, a family nurse practitioner in the College of Nursing at the University of Central Florida in Orlando, Fla. "It was a pleasant surprise to find that the results showed substantial financial benefit for employees at practically any salary level."

Lima and co-investigator Dr. Elizabeth M. Rash, who is also a nurse practitioner, applied epidemiological data related to OSA screening, diagnosis and treatment to the specific demographics of the corporation. They based their calculations on statistics that 70 percent of high-risk individuals are diagnosed with OSA, and that 75 percent of patients with OSA are compliant with CPAP therapy. Therefore, they estimated that 319 of the 608 high-risk employees would have OSA and be compliant with treatment.

Then Lima and Rash made conservative statistical estimates, considering lost work productivity as the variable and using half of its predicted value. For each of the 319 treated employees, productivity was estimated at $150,000 per year. Recovering the 30 percent of productivity that was lost due to OSA would yield an annual gain of $14.4 million. Estimating the cost of diagnostic screening with polysomnography and treatment with CPAP therapy to be $7.2 million over 10 years, Lima and Rash determined that the corporation would have a 10-year net savings of $136 million.

Lima added that both companies and employees reap benefits when OSA is diagnosed and treated.


"Companies may become proactive in screening and treating their employees for OSA due to the predicted financial benefit," she said. "The importance goes beyond the improved cognitive function and savings of millions of dollars in work performance, since treating OSA adds other health benefits."

According to the American Academy of Sleep Medicine, it is estimated that about 80 to 90 percent of adults with OSA remain undiagnosed. OSA is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. It occurs when the muscles relax during sleep, causing soft tissue in the back of the throat to collapse and block the upper airway. This leads to partial reductions (hypopneas) and complete pauses (apneas) in breathing that can produce abrupt reductions in blood oxygen saturation and reduce blood flow to the brain. Most people with OSA snore loudly and frequently, and they often experience excessive daytime sleepiness.

The treatment of choice for OSA is CPAP therapy, which provides a steady stream of air through a mask that is worn during sleep. This airflow keeps the airway open to prevent pauses in breathing and restore normal oxygen levels. Help for OSA is available at more than 2,200 AASM-accredited sleep disorders centers across the U.S.

Source: American Academy of Sleep Medicine


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