Sommetrics has completed clinical study SOM-014, a trial which evaluated the safety, tolerability and effectiveness of the Sommetrics aerSleep product in ethnic Japanese subjects with obstructive sleep apnea (OSA).
This was a prospective, observational study conducted at the American Academy of Sleep Medicine accredited Sleep Lab in Kaneohe, Hawaii. In a cohort of subjects with moderate to severe OSA, use of the aerSleep device was effective in reducing the frequency of apneas and hypopneas by 75% from baseline levels in responsive subjects. No significant adverse events were observed. During the home use portion of the study, aerSleep was well tolerated as evidenced by average nightly usage of 5.7 hours during the second week of therapy.
“We are delighted to verify that aerSleep has a treatment profile in ethnic Japanese people that is comparable to what we’ve observed in Caucasian populations,” commented Dr. Richard Rose, President, CEO and Chief Medical Officer of Sommetrics. ”This is an important consideration in view of the differences in configuration of the maxilla-facial structures between some Asians and Caucasians. It is reassuring to observe that such differences do not appear to affect the treatment benefits of aerSleep for the large worldwide markets that have a predominately Asian demographic.”
The principal investigator, Dr. Jamil Sulieman, had these remarks: “aerSleep proved to be effective and well-tolerated in this small group of ethnic Japanese subjects. It was relatively simple to fit and initiate treatment with this device, which has a number of advantages over current therapies like continuous positive airway pressure (CPAP). I look forward to adding aerSleep to my treatment options for OSA.”
The aerSleep system consists of a comfortable silicone collar fitted on the front of the neck which holds the airway open via the application of external negative pressure delivered by a quiet, integrated vacuum pump. This system has a number of advantages over conventional sleep apnea therapies in that it is non-invasive, simple to use and maintain, highly portable and well tolerated by the majority of users. An earlier version of aerSleep has previously received market clearance from HealthCanada.
Source: Company Press Release