Apple has unveiled its new Series 10 Apple Watch and one of the new health tracking features is sleep apnoea notifications.
The sleep apnoea feature is not approved by the US Food and Drug Administration (FDA). However, the company expects to receive marketing authorisation from the US and other global regulatory bodies by the end of September, as the tech giant looks to roll out the sleep apnoea notifications across 150 countries this month.
Apple will use the accelerometer in the watches to monitor small movements at the wrist that are associated with interruptions in normal respiratory patterns, tracked as breathing disturbances, to detect sleep apnoea. These nightly breathing disturbances will be classed as elevated or not elevated, as frequent disturbances over multiple nights may be associated with sleep apnoea.
The company has also developed a sleep apnoea algorithm to analyse the breathing disturbance data and notify its users of “consistent signs of sleep apnoea”. The sleep apnoea notification will include a period of potential sleep apnoea, education materials on seeking treatment for the disease and a PDF containing the sleep apnoea data along with other data which can be used to have an informed conversation with a healthcare provider.
The sleep apnoea feature was developed using machine learning in the clinical sleep apnoea test dataset. The algorithm was then validated in a clinical study. Apple noted that “every participant identified by the algorithm [in the clinical validation study] had at least mild sleep apnoea”.
Apple has a variety of health-tracking features for its watches and other devices and has also partnered with other apps to expand its health offerings. In September 2023, Natural Cycles received 510(k) clearance from the FDA to use wrist temperature data from the Apple Watch. The app uses daily hormone-driven temperature changes to assess the user’s fertility.
As per a GlobalData report, the market size of wearable technology in the medical sector in 2023 is projected to exceed $100bn and is expected to grow at a compound annual growth rate of 15% up to 2030.
Despite the market uptake, the sector has had its share of controversies. In February 2024, the FDA cautioned the use of smartwatches for measuring glucose levels. The regulator stated that despite multiple smartwatches and smart rings claiming to measure blood glucose, the FDA denied having “authorised, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own”.
