10 Oct FDA grants Apple clearance for its sleep apnoea notification feature on their Apple Watch.
On September 9, 2024, Apple unveiled the Apple Watch Series 10, marking a significant milestone in health technology with its innovative obstructive sleep apnoea (OSA) notifications. This new model not only features a sleeker design and a larger display but also introduces vital health tracking capabilities, including heart rate, respiratory rate, and wrist temperature.
The Apple Watch Series 10 represents a breakthrough in the identification of moderate to severe OSA in adults aged 18 and older. By utilizing an advanced accelerometer, the watch detects subtle movements that signal disruptions in normal breathing patterns, enabling it to track episodes of restless sleep. The introduction of the “breathing disturbances” metric is crucial, as it allows users to recognize consistent signs of OSA, a condition that can have serious health implications.
Users can conveniently access detailed nightly data through the Health app on their iPhone, where breathing disturbances are classified as elevated or not elevated. The watch’s intelligent algorithm proactively alerts users when it detects ongoing signs of OSA, providing essential educational materials and a comprehensive PDF with three months of historical data to aid discussions with healthcare professionals.
Clinically Validated Technology
Apple emphasizes that the notification algorithm was developed through cutting-edge machine learning techniques and rigorously validated in extensive clinical studies. On September 13, 2024, Apple received FDA 510(k) clearance for this vital sleep apnoea notification feature, which is supported on Apple Watch Series 9, Series 10, and Apple Watch Ultra 2.
The Importance of Understanding OSA
Obstructive sleep apnoea is a widespread and serious disorder characterized by repeated airway blockages during sleep, leading to dangerous pauses in breathing and decreased oxygen levels. Symptoms such as loud snoring, choking, and frequent awakenings can contribute to severe health problems, including high blood pressure, heart disease, stroke, diabetes, and depression.
Take This With a Grain of Salt
Whilst this technology is exciting and useful, be mindful that all the devices available in the market that use this type of technology are deliberately programmed to overestimate sleep staging and breathing disturbances.
My advice to you is to use this data only as a screening method to seek professional attention and get appropriate gold-standard polysomnography (PSG) testing, and not as a diagnostic tool, let alone as evidence to acquire treatment without the prescription and/or supervision of a certified sleep physician.