苹果 Apple Watch 睡眠呼吸暂停功能正式上线

苹果于10月14日凌晨在中国大陆正式推出Apple Watch睡眠呼吸暂停通知功能，该功能已获得国家药品监督管理局批准，被纳入二类医疗器械管理1。该功能支持Apple Watch Series 9、Ultra 2和SE 3及后续机型，面向年满18岁且未被诊断过睡眠呼吸暂停的用户1。

功能采用加速度感应器检测用户的呼吸模式，以30天为一个评估周期，用户需在周期内至少佩戴10晚1。当检测到超过半数夜晚出现呼吸紊乱指数上升时，系统将向用户发出通知1。苹果的算法基于超过11000晚的配对数据训练，临床验证参与了近1500名受试者1。验证结果显示该功能的敏感度为66.3%，特异度为98.5%，对重度患者的敏感度可达89.1%1。

全球患病率已升至24%以上，中国患者约1.76亿人，但其中约80%的患者不知道自己患病1。该功能旨在帮助未诊断患者进行初步筛查。苹果选择仅通过加速度感应器进行检测，而未采用血氧监测方案1。

Apple officially introduced the sleep apnea notification feature for Apple Watch in mainland China on October 14, marking the availability of a clinically validated health monitoring capability 1. The feature has received approval from China's National Medical Products Administration as a Class II medical device 1.

The sleep apnea detection function is compatible with Apple Watch Series 9, Ultra 2, and SE 3 models, as well as subsequent releases 1. It targets users aged 18 and above who have not previously been diagnosed with sleep apnea 1. The system operates on a 30-day assessment cycle, requiring at least 10 nights of wear to generate results 1. Detection relies solely on the device's accelerometer to identify breathing irregularities, without utilizing blood oxygen monitoring 1.

The algorithm was trained using data from over 11,000 nights of paired measurements and underwent clinical validation involving approximately 1,500 study participants 1. Results demonstrated 66.3% sensitivity and 98.5% specificity overall, with sensitivity reaching 89.1% for severe apnea cases 1. When the disruption index rises on more than half of the monitored nights, the watch sends a notification to prompt further medical evaluation 1. The feature is designed to facilitate initial screening for undiagnosed patients, as approximately 80% of the estimated 176 million sleep apnea patients in China remain unaware of their condition 1.