Withings has received a clearance from the FDA for what it describes as the first device that can help diagnose a person with obstructive sleep apnea without the need for any wearable sensors, wires, masks or straps.
The company’s contactless Sleep Rx mat is placed underneath the user’s own mattress, and tracks the sleeper’s heart rate, breathing and body movement over the course of several nights. The prescription equipment also logs the duration and quality of sleep cycles, in addition to snores and other respiratory disturbances.
Typically, diagnosing obstructive apnea may require an overnight stay in a sleep lab for a polysomnography test—a far from restful proposition, often involving separate, tethered sensors to measure airflow, brain activity, blood oxygen levels and overall physical breathing efforts.
Those tests can be expensive and have limited availability, and a single night of data may not paint a full picture of a patient’s condition. Withings estimates that of the about 30 million people in the U.S. with obstructive sleep apnea, about 80% of cases may be going undiagnosed and untreated—while increasing a person’s risks of developing severe cardiovascular and metabolic diseases.
“Enabling earlier and more precise diagnosis, Sleep Rx creates a new sleep apnea diagnosis and management paradigm. We know that a one-night assessment is not sufficient,” Antoine Robiliard, VP of Withings Health Solutions, said in a statement.
“By enabling more efficient and lower-cost home-based OSA diagnosis, Sleep Rx could not only reduce the staggering $150 billion annual economic burden of undiagnosed sleep apnea but also significantly improve long-term health outcomes,” Robiliard added.
According to the company, a study of over 11 million nights showed high variability in a user’s night-to-night measures of reduced or restricted airflow, demonstrating the need for longitudinal data. An internal study of Withings connected sleep mats, which is also available as a non-prescription version without OSA detection, showed 87% were used for at least one year.