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Apple Watch Sleep Apnea Notifications Launch in Mainland China

Apple has brought sleep apnea notifications to mainland China on supported Apple Watch models after NMPA approval. The feature flags possible moderate-to-severe sleep apnea but does not diagnose it.

Supported devices include Apple Watch Series 9 and later, Apple Watch Ultra 2 and later, and Apple Watch SE 3, Aifanr reported. That includes the latest Apple Watch Series 12 and Apple Watch Ultra 4, according to Shaoshupai. Users must update their iPhone and Apple Watch to the latest iOS and watchOS, enable sleep tracking and complete setup in the Health app. Aifanr reported that the feature is limited to users 18 or older who have not been previously diagnosed with sleep apnea.

The system works through the Apple Watch accelerometer. Shaoshupai reported that the watch captures subtle body movements associated with breathing and analyzes them for breathing disturbances. Apple's algorithm development used 2,160 participants and 3,936 nights of home or laboratory polysomnography data, followed by validation with 2,542 participants and 7,220 nights, according to Shaoshupai. The company said the resulting breathing disturbance data fell within an acceptable error range of true apnea-hypopnea index values in 91.4% of cases.

The feature does not provide a real-time alarm when breathing stops. Aifanr reported that users need at least 10 nights of valid sleep data within 30 days, after which the system performs an assessment every 30 days. If at least half of the valid nights show elevated breathing disturbances, the watch may send a notification about possible moderate-to-severe sleep apnea. Users can view nightly breathing disturbance results and trends over one, six or 12 months in the Health app, and export a PDF health report for a doctor.

Apple has positioned the feature as a risk alert, not a diagnostic tool. Shaoshupai reported that the FDA cleared it as an over-the-counter device to assess the risk of sleep apnea, and that Apple Watch itself is not a medical device. The company's clinical validation reported 66.3% weighted sensitivity for participants with confirmed moderate-to-severe sleep apnea and 98.5% weighted specificity for mild or normal participants; among normal participants, specificity was 100%, according to Shaoshupai. The design favors avoiding false positives, meaning a notification suggests the user should seek evaluation, but no notification does not rule out the condition.

Sleep apnea is common and often undiagnosed. Aifanr reported that more than 1 billion people worldwide have sleep apnea and nearly 80% have not been diagnosed. Shaoshupai reported that obstructive sleep apnea, the most common type, occurs when the upper airway becomes blocked during sleep, causing repeated breathing pauses, drops in blood oxygen and brief awakenings. It can lead to daytime fatigue, morning headaches and increased risk of cardiovascular and cerebrovascular disease. Traditional diagnosis often requires an overnight polysomnography in a hospital, which is expensive and can disrupt sleep, while home tests still require multiple devices.

Shaoshupai reported that South Korea's Ministry of Food and Drug Safety approved a sleep apnea detection app for Samsung Galaxy Watch 5 and later in October last year, using blood oxygen changes. Aifanr reported that Apple CEO Tim Cook, in a recent interview in Beijing, described Apple Watch as a future personal health guardian.