US-based Sommetrics has concluded clinical trial SOM-014, evaluating the safety, tolerability and effectiveness of the aerSleep device in ethnic Japanese subjects with obstructive sleep apnea (OSA).
The prospective, observational study was conducted at the American Academy of Sleep Medicine accredited Sleep Lab in Kaneohe, Hawaii.
Use of the aerSleep device was found to be effective in a cohort of subjects with moderate to severe OSA, reducing the frequency of apneas and hypopneas by 75% from baseline levels in responsive subjects.
The trial did not report any significant adverse events.
The device was well tolerated during the home use portion of the study, as evidenced by an average nightly usage of 5.7 hours during the second week of therapy.
Sommetrics president, CEO and chief medical officer Dr Richard Rose said: “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.
“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.”
A comfortable silicone collar fitted on the front of aerSleep’s users neck holds the airway open through the application of external negative pressure delivered by an integrated vacuum pump.
The portable system is non-invasive, simple to use and maintain and well tolerated by the majority of users.
Health Canada has previously granted approval to an earlier version of aerSleep.