Results of a definitive clinical trial show that a new, disposable diagnostic patch effectively detects obstructive sleep apnea across all severity levels. [Image from Somnarus, Inc.]
The results showed that the SomnaPatch device had a clinical agreement between the patch and standard polysomnography of 87.4%, with 95% confidence interval of 81.4% to 91.9%, according to its maker Somnarus.
SomnaPatch weighs less than 1 ounce and is a diagnostic patch that sticks to the skin. It records nasal pressure, blood oxygen saturation, pulse rate, respiratory effort, sleep time and body position.
“Our study provided clinical validation of a new wearable device for diagnosing sleep apnea,” said principal investigator Maria Merchant, PhD, CEO of Somnarus, in a press release. “It was most surprising to us how well this inexpensive miniature device performed in comparison with in-lab sleep studies.”
Recordings from polysomnography and patch recordings of 174 people were analyzed in the clinical trial. A home usability study also suggested that 38 out of 39 people were able to activate the patch from home and collect at least 4 hours of sleep data.
“Most home sleep diagnostic devices are difficult for patients to use and are disruptive to patient’s sleep,” Merchant said. “Our study showed that this wearable home sleep monitor is very comfortable, easy to use and does not negatively affect sleep.”
Sleep apnea occurs when there is a pause in breathing or shortness of breath while sleeping. About 22 million Americans currently have sleep apnea, according to the American Sleep Apnea Association.
Traditional sleep apnea diagnoses have patients sleep through the night in a sleep laboratory that monitors blood oxygen levels, respiration, brain-wave activity, leg movements and the apnea-hypopnea index.
Somnarus executives think the study results will help the company makes its case to FDA for theSomnaPatch. A National Institutes of Health grant supported the research, whichwas published online in the journal Sleep.
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