The U.S. Food and Drug Administration has issued clearance to Resonea for an in-home sleep apnea screening device, according to a July 25, 2019, statement issued by the company. Drowzle is a prescription smartphone-based device that tracks symptoms and records breathing patterns during sleep that might indicate a risk for sleep apnea.
Identifying Apnea Risks
Drowzle has no sensors that attach to the body. It records sleep breathing sounds and patterns, sending the audio files to a secure server for computer analysis. The consumer also uses the smartphone software to report symptoms of sleep apnea such as daytime sleepiness and personal risk factors such as obesity or high blood pressure. Reports are provided to the user and his or her health care providers for further evaluation and testing.
Resonea reports that a study compared the data collected by Drowzle to the polysomnography results of patients undergoing a sleep study in a sleep center. The company states that Drowzle’s algorithm was highly sensitive in the detection of moderate and severe obstructive sleep apnea. The device also includes validated sleep apnea risk questionnaires that could reduce the potential for false negative results, according to Resonea.
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