In a September 9, 2024 press release, Withings Health Solutions announced it has received clearance from the FDA for its Sleep RX Mat, the “First Contactless Device to Aid for Sleep Apnea Diagnosis”.1
Obstructive Sleep Apnea (OSA) has been described as a “hidden health crisis” affecting approximately 30 million adults in the U.S. with only 6 million officially diagnosed, leaving 80% of Sleep Apnea cases undiagnosed.2
Withings suggests limitations in traditional diagnostic solutions may be to blame for the underdiagnosis of OSA and believes the release of the Sleep RX Mat will “pave the way to better health outcomes for millions of adults in the U.S.” who currently suffer from Obstructive Sleep Apnea.1
Current Methods
Current diagnostic methods include Polysomnography, commonly known as a sleep study, which records your brain waves, blood oxygen levels, and heart rate/breathing while you sleep to detect a sleep disorder. A Polysomnography can identify if your sleep patterns are disrupted, when, and why.
A sleep study is typically performed at a sleep center where you will stay overnight. Cost and access to care have been sited as limitations to an on-site Polysomnography.3 4
There are home sleep apnea tests available using different types of devices. Many patients prefer the convenience of a home sleep apnea test and insurance providers consider it a cost-effective alternative. Some find the home sleep test to be less effective, measuring breathing rather than sleep, leading to inconclusive results or a false negative. Due to these limitations, it is recommended that only patients considered to be at high risk of sleep apnea should use a home sleep test. In addition, patients with certain pre-existing conditions are not candidates for these home sleep test devices.5
Sleep Rx
The Sleep Rx has been clinically validated to “provide a detailed analysis of sleep, breathing, and cardiovascular activity throughout the night”. Sleep Rx is now available in the U.S. by prescription. The Sleep Rx Mat fits under your mattress and does not require a mask or other equipment. The Sleep Rx allows for continual tracking of sleep to deal with the “revealed significant variability in the apnea-hypopnea index (AHI) from night to night”.1
It is important to diagnose and treat Obstructive Sleep Apnea due to potential long-term health consequences. Studies have shown that patients who go undiagnosed may be at greater risk of diabetes, stroke and heart disease.6
“We’re thrilled to bring Sleep Rx to the U.S. market,” said Antoine Robiliard, VP of Withings Health Solutions. “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. 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.”1
