SomnaPatch may identify obstructive sleep apnea without observation in a clinic.
Patients with suspected sleep apnea may have to undergo observation at a sleep clinic for diagnosis, in addition to a review of medical history and a physical examination.
Physicians may recommend a polysomnogram (PSG) for patients with suspected sleep disorders, such as sleep apnea. This type of test is typically conducted at a sleep center or sleep laboratory, in which patients are instructed to sleep with sensors attached to their scalp, face, chest, limbs, and finger, according to the National Heart, Lung, and Blood Institute (NHLBI). A sleep specialist will then determine the severity of sleep apnea and assign treatment.
Results from a new clinical trial published by Sleep suggest that a disposable diagnostic patch may be able to accurately diagnose sleep apnea, regardless of severity.
The authors discovered that the clinical agreement between the novel patch and PSG was 87.4% with 95% confidence interval of 81.4% to 91.9%. These overwhelmingly positive results will be used to seek FDA approval for the SomnaPatch, according to the authors.
The SomnaPatch weighs less than 1 ounce and adheres to the skin to record nasal pressure, blood oxygen saturation, pulse rate, respiratory effort, sleep time, and body position, according to the study.
"Our study provided clinical validation of a new wearable device for diagnosing sleep apnea," said principal investigator Maria Merchant, PhD, CEO of Somnarus Inc. "It was most surprising to us how well this inexpensive miniature device performed in comparison with in-lab sleep studies."
Included in the study were PSG and patch recordings for 174 patients.
The investigators found that nearly all patients were able to activate the diagnostic patch and collect at least 4 hours of sleep data, according to the study. Patients were able to do so using the device’s instructions.
While in-home sleep studies are conducted, the SomnaPatch may provide additional benefits. Traditional in-home studies include the use of a portable monitor that records the same information as a traditional PSG; however, certain patients may still require a full PSG study in a sleep clinic, according to the NHLBI. The SomnaPatch has shown efficacy in diagnosing patients with sleep apnea across all severity levels and has the added benefit of being disposable, according to the study.
"Most home sleep diagnostic devices are difficult for patients to use and are disruptive to patient's sleep," Dr Merchant said. "Our study showed that this wearable home sleep monitor is very comfortable, easy to use and does not negatively affect sleep."