FDA Grants IDE Approval for Sommetrics Sleep Apnea Trial

Sommetrics has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application to conduct a pivotal in-home clinical trial of its aerSleep II system. aerSleep earned Breakthrough Device Designation status last fall.

The Study Using negative Pressure to Reduce Apnea (SUPRA) clinical trial will evaluate the safety and effectiveness of the aerSleep II device for treatment of moderate to severe Obstructive Sleep Apnea (OSA) over 24 weeks of home use in subjects who are intolerant of Continuous Positive Airway Pressure (CPAP) therapy. The study will be conducted at 10 sites located in Arizona, Florida (south), Ohio, Pennsylvania (east and west) and South Carolina. Sommetrics will provide additional information regarding the SUPRA trial on its website as contracts and Institutional Review Board (IRB) approvals are finalized with the study sites. The FDA has previously designated the aerSleep II system as a Breakthrough Device for treating OSA, which facilitates communications with the FDA and may accelerate reimbursement negotiations after marketing clearance.
 
The SUPRA clinical trial’s principal investigator, Dr. Kingman Strohl (program director in Sleep Medicine, University Hospitals Cleveland Medical Center, and professor of Medicine, Case Western Reserve University, Cleveland, Ohio) stated, “OSA is a major public health concern which detrimentally affects the quality of life for up to 20 percent of Americans. Sommetrics’ aerSleep system offers a first-in-class, comfortable, silent and non-invasive option for treating OSA sufferers. Although CPAP therapy is very effective, it is typically only used for about half of a subject’s sleep time and only about half of patients who are prescribed PAP therapy tolerate long term use of the treatment. There is an urgent need for alternative treatment options.”
 
aerSleep II uses a soft silicone collar to apply mild negative pressure over the external surface of the neck to hold the airway open during sleep. It is a small self-contained unit with an integrated vacuum pump which is quiet and easy to use and maintain. The unit is portable and held in place without the need for a retaining strap. It allows users to easily talk and swallow without anything on their face or in their mouth. Also, it does not spread infectious aerosols from the user’s airway like CPAP. In previous clinical studies, there was a strong subject preference for aerSleep over previously used therapies like CPAP and oral devices.