ARTICLE SUMMARY:
Onera Health just received FDA clearance for the first patch-based polysomnography system for home use. It will soon begin to meet a demand for sleep studies that conventional sleep centers just can’t handle. For the future, physiological monitoring during sleep has all kinds of clinical possibilities.
Good sleep is necessary for vibrant health and quality of life, yet most of the 70 million people in the US with a sleep disorder don’t get diagnosed, and that’s largely because of the current testing paradigm, which requires patients to spend a night of monitoring in a sleep laboratory. There’s not enough capacity to study all the patients who might suffer from any of 80 possible sleep disorders, the top four being obstructive sleep apnea (OSA), insomnia, restless legs syndrome, and narcolepsy. For example, OSA affects about 20% of the US population, but 90% of people with this form of sleep disordered breathing are undiagnosed and are therefore untreated for a medical condition that can hasten the development of heart disease.
In 2017, a team of medical and nanotechnology experts founded Onera Health (Eindhoven, The Netherlands) to streamline the entire sleep diagnostic process, from the moment a referring physician prescribes a test to the delivery of results analyzed via the Cloud to the sleep specialist, who can then provide further review and initiate therapy, where necessary. (For more on Onera Health’s beginnings, see “Beyond Sleep Apnea, Sleep Tech Tackles Chronic Diseases,” MedTech Strategist, July 25, 2019.)
