A clinical trial has demonstrated that Somnarus' new, disposable diagnostic patch effectively identifies obstructive sleep apnea across all severity levels.
The data from the study will be helpful to secure approval from the US Food and Drug Administration for the SomnaPatch device.
According to American Academy of Sleep Medicine, the results demonstrated that the total rate of clinical agreement between the patch and standard in-lab polysomnography was 87.4% with 95% confidence interval of 81.4% to 91.9%.
Based on algorithms and methods, SomnaPatch records respiratory patterns, pulse oximetry data and estimates sleep time
The skin-adhesive diagnostic patch, which weighs less than one ounce, will record nasal pressure, blood oxygen saturation, pulse rate, respiratory effort, sleep time and body position.
Somnarus CEO and study principal investigator Maria Merchant said: “Our study provided clinical validation of a new wearable device for diagnosing sleep apnea.
“It was most surprising to us how well this inexpensive miniature device performed in comparison with in-lab sleep studies.”
The study included the simultaneous polysomnography and patch recordings of 174 subjects, which were analysed.
An additional home usability study demonstrated 38 out of 39 users have been successful in activating the diagnostic patch and collecting around four hours of sleep data while depending only on the instructions included with the device.
Merchant added: “Our study showed that this wearable home sleep monitor is very comfortable, easy to use and does not negatively affect sleep.”
Image: Somnarus’ new diagnostic patch can detect obstructive sleep apnea across all severity levels. Photo: courtesy of David Castillo Dominici / FreeDigitalPhotos.net.