Apple Watch 睡眠呼吸暂停检测获得 FDA 批准
Apple Watch sleep apnea detection gets FDA approval

原始链接: https://techcrunch.com/2024/09/16/apple-watch-sleep-apnea-detection-gets-fda-approval/

9 月 19 日,美国食品和药物管理局 (FDA) 批准了 Apple Watch Series 9、10 和 Watch Ultra 2 的睡眠呼吸暂停检测功能。这项新功能是在最近的 iPhone 16 发布会上宣布的,并将通过 即将推出的 watchOS 11 更新。 要使用此功能,您的手表必须跟踪一个月内 10 个不同的睡眠时段。 在此期间之后,手表通过使用内置加速度计分析夜间干扰来识别与睡眠呼吸暂停相关的任何潜在问题。 尽管它不能提供明确的诊断,但 FDA 认为该功能是一种非处方设备,旨在检测睡眠呼吸暂停的可能风险。 如果发现,您应该咨询医疗专业人士进行进一步评估。 睡眠呼吸暂停会扰乱睡眠期间的正常呼吸模式,导致各种健康问题,如失眠、头痛、白天过度嗜睡以及心脏病和中风等长期并发症。 虽然多家科技公司已经提供睡眠呼吸暂停监测技术,但 Withings 和三星此前已获得 FDA 批准。 然而,由于专利纠纷,苹果不得不禁用在美国销售的手表上的血氧水平测量功能。

一个人讲述了他们患有睡眠呼吸暂停的个人经历以及他们尝试过的治疗方法。 他们分享了有关症状的详细信息,例如呼吸暂停和响亮的口哨声,这些症状可以追溯到童年时期。 他们将这些发作归因于未确诊的睡眠呼吸暂停。 他们的治疗之旅始于 90 年代末,在伴侣的鼓励下并发现了他们不寻常的呼吸模式。 尽管尝试了持续气道正压通气 (CPAP) 机器,但该人发现很难持续使用它们。 几年后,奇怪的呼吸模式消失了,睡眠质量和醒来时的警觉性都得到了改善。该人后来发现了Inspire,这是一种植入式设备,旨在通过电刺激舌下神经以在睡眠期间保持气道开放来治疗睡眠呼吸暂停。 手术涉及将组件放置在皮肤下,以及用于电源管理和刺激强度调整的手持遥控器。 康复过程中包括因神经操作导致的胸部疼痛、体力活动受限,并且需要几个月的康复和训练才能达到最佳功能。 总体而言,尽管 Inspire 成本高昂且保险范围有限,但个人认为 Inspire 有效。 此外,他们强调满足特定标准以获得手术资格的重要性,包括保持健康的体重指数 (BMI) 和 CPAP 等传统疗法的失败。 最后,他们建议咨询专家并寻求在线支持小组以获得处理睡眠呼吸暂停的指导。
相关文章

原文

The U.S. Food and Drug Administration Monday published approval for sleep apnea detection on the Apple Watch Series 9, Series 10, and Watch Ultra 2. The green light comes four days ahead of the Series 10’s September 20 release date.

The feature, announced at last week’s iPhone 16 event, will arrive as part of the imminent watchOS 11 release. Once enabled, it requires 10 nights of sleep tracking data spread out over a 30-day span to determine whether a user may have the condition. During that time, it also offers insights into nightly sleeping disturbances, utilizing the on-board accelerometer.

The FDA classes the feature as an “over-the-counter device to assess risk of sleep apnea.” Apple is quick to note that the addition is not a diagnostic tool. Rather, it will prompt users to seek a formal diagnosis from a healthcare provider. The condition, which causes breathing to become shallower or repeatedly stop during the night, is associated with a variety of different symptoms. The Mayo Clinic notes that it can cause insomnia, headaches, daytime sleepiness, and other longer-term conditions.

Apple isn’t the first consumer electronics firm to offer the feature. Withings has offered sleep apnea detection in devices for some time, while Samsung received FDA approval for its Galaxy Watch line earlier this.

The feature arrives as another — blood oxygen detection — has been disabled on Apple Watches in the U.S. over an ongoing patent dispute.

联系我们 contact @ memedata.com