VP of Withings Health Solutions talks newly FDA approved Sleep RX device

Sleep RX is a mat that fits under any mattress to diagnose sleep apnea without a mask

Roughly 30 million adults in the U.S. have Obstructive Sleep Apnea (OSA), with millions of patients going undiagnosed, which can increase the risk of a number of diseases, including diabetes mellitus, resistant hypertension, atrial fibrillation, stroke, and myocardial infarction. 

French wearables company Withings' solution is its Sleep Rx device, which can be used in the home to screen of adults with suspected sleep breathing disorders to diagnosis OSA, sleep analysis, and heart rate estimation. The mat fits under any mattress, eliminating the need for masks or cumbersome equipment.

Now the device will be available to consumers across the U.S. as the the company announced earlier this week that the Sleep Rx Mat has received clearance from the U.S. Food and Drug Administration (FDA), meaning consumers will be able to use it when prescribed as part of clinical sleep management or remote patient monitoring program.

Antoine Robiliard, VP of Withings Health Solutions, spoke to VatorNews about the dangers of sleep apnea, how Sleep RX helps with diagnosis, and the company's ultimate goal.

VatorNews: I have sleep apnea and I only found out because my girlfriend heard me breathing at night and recognized the symptoms, otherwise I might never have known. Why is it that so many sleep apnea cases go undiagnosed? What barriers currently exist to people getting diagnosed and treated? Why do so many sleep apnea cases go undiagnosed, and what barriers exist to diagnosis and treatment?

Antoine Robiliard: Sleep apnea affects approximately 30 million adults in the U.S., but about 80% of cases remain undiagnosed. This underdiagnosis is primarily due to a lack of awareness, limited access to diagnostic tools, and inadequate sleep environments. Many individuals may not recognize the symptoms themselves and may only become aware if someone else notices. 

Traditional diagnostic methods, like polysomnography (PSG)  are limited to diagnosing only the most severe sleep disorders due to their low availability and high cost. PSG is also bulky and intrusive, requiring an overnight stay in a sleep lab, which many patients find inconvenient. Moreover, a single-night assessment may not accurately represent the severity of OSA, as it can fluctuate from night to night, leading to potential error rates of up to 50%. A major factor of Sleep Rx is that it can be used in the comfort of a home over a long period of time, providing more data for analysis. 

A Real-World Data study by the Flinders Health and Medical Research Institute in Australia, involving data from over 11 million nights recorded with Withings sleep tracking mat, highlighted the importance of longer-term monitoring due to high variability in apnea severity from night to night.

VN: How dangerous is it for someone not to get an accurate diagnosis? What can the ultimate outcomes be?

AR: Not getting an accurate diagnosis for sleep apnea can lead to severe health consequences, including increased mortality rates and complications from comorbid conditions such as hypertension as well as affecting peoples’ quality of life as they may suffer from daytime fatigue, attention deficit, migraines and more.

The underdiagnosis of OSA is highly problematic because untreated OSA significantly increases cardiometabolic risks, including diabetes mellitus, resistant hypertension, atrial fibrillation, stroke, and myocardial infarction..

VN: How does Sleep Rx help solve these problems? What's different about your product?

AR: Sleep Rx is an advanced sleep monitor that can aid in the detection of sleep apnea, by analyzing sleep patterns, and monitoring heart rate using a non-invasive mat that fits under any mattress. It requires no cumbersome equipment, making it easier for patients to use and allows at-home screening over a period of time, rather than in a single night.  By offering continuous monitoring at home, Sleep Rx addresses the variability in apnea severity, which often goes unnoticed with traditional, single-night clinical assessments. This product allows for a more accurate and comprehensive diagnosis, which is crucial for effective treatment and management of sleep apnea and is less expensive and more convenient than the traditional PSG method.

VN: How accurate is Sleep Rx in diagnosing Sleep Apnea? Can you provide hard numbers?

AR: Sleep Rx has been validated in global studies and supports earlier and more precise stratification of patients, facilitating improved continuum of care that can reduce mortality rates associated with sleep apnea and related conditions.  

A published study on the Validation of the Withings Sleep Analyzer, an under-the-mattress device for the detection of moderate-severe sleep apnea syndrome can be found here. Withings Sleep Analyzer is a Withings sleep tracking mat, CE-marked, distributed in Europe, equivalent to Sleep Rx.

VN: What happens after a person uses the device to get diagnosed for sleep apnea? What are the next steps?

AR: Sleep Rx is an aid for diagnosing sleep apnea. After diagnosis by a doctor, patients can continue to use Sleep Rx for ongoing monitoring as part of their sleep management and remote patient monitoring process. The device helps monitor the patient and provides valuable insights into their condition, which empowers both patients and healthcare providers to manage the condition more effectively.

VN: What is the ultimate goal with Sleep Rx? What will you see as success with this product?

AR: The ultimate goal of Sleep Rx is to transform sleep apnea diagnosis and management by making it more accessible, accurate, and comprehensive. Success with this product would be measured by its ability to significantly impact the patient journey, improve adherence to treatment, and ultimately reduce the mortality rates and complications associated with sleep apnea.

VN: Is there anything else that I should know?

AR: Sleep Rx represents a major advancement in connected health, bridging the gap between patients and their care teams by providing medical-grade data continuously and effortlessly. It’s available in the U.S. exclusively by prescription and aims to make the diagnosis and management of sleep apnea as seamless as possible for millions of patients. Furthermore, Sleep Rx is compatible with Withings Remote Patient Monitoring (RPM) giving better access to patient data to a health professional. 

(Image source: withings.com)