Sleep Medicine Section, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.
Division of Pulmonary, Critical Care, and Sleep Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio.
J Clin Sleep Med. 2024 Nov 1;20(11):1823-1838. doi: 10.5664/jcsm.11290.
From 2019-2023, the United States Food and Drug Administration has cleared 9 novel obstructive sleep apnea-detecting wearables for home sleep apnea testing, with many now commercially available for sleep clinicians to integrate into their clinical practices. To help clinicians comprehend these devices and their functionalities, we meticulously reviewed their operating mechanisms, sensors, algorithms, data output, and related performance evaluation literature.
We collected information from PubMed, United States Food and Drug Administration clearance documents, ClinicalTrials.gov, and web sources, with direct industry input whenever feasible.
In this "device-centered" review, we broadly categorized these wearables into 2 main groups: those that primarily harness photoplethysmography data and those that do not. The former include the peripheral arterial tonometry-based devices. The latter was further broken down into 2 key subgroups: acoustic-based and respiratory effort-based devices. We provided a performance evaluation literature review and objectively compared device-derived metrics and specifications pertinent to sleep clinicians. Detailed demographics of study populations, exclusion criteria, and pivotal statistical analyses of the key validation studies are summarized.
In the foreseeable future, these novel obstructive sleep apnea-detecting wearables may emerge as primary diagnostic tools for patients at risk for moderate-to-severe obstructive sleep apnea without significant comorbidities. While more devices are anticipated to join this category, there remains a critical need for cross-device comparison studies as well as independent performance evaluation and outcome research in diverse populations. Now is the moment for sleep clinicians to immerse themselves in understanding these emerging tools to ensure our patient-centered care is improved through the appropriate implementation and utilization of these novel sleep technologies.
Chiang AA, Jerkins E, Holfinger S, et al. OSA diagnosis goes wearable: are the latest devices ready to shine? . 2024;20(11):1823-1838.
自 2019 年至 2023 年，美国食品和药物管理局已批准 9 种新型用于家庭睡眠呼吸暂停检测的阻塞性睡眠呼吸暂停检测可穿戴设备，其中许多现已可商业购买，供睡眠临床医生将其整合到临床实践中。为帮助临床医生理解这些设备及其功能，我们仔细审查了它们的工作机制、传感器、算法、数据输出以及相关性能评估文献。
我们从 PubMed、美国食品和药物管理局批准文件、ClinicalTrials.gov 和网络资源中收集信息，并在可行的情况下直接从行业获得输入。
在本次“以设备为中心”的综述中，我们将这些可穿戴设备广泛分为 2 大主要类别：主要利用光体积描记数据的设备和不利用光体积描记数据的设备。前者包括基于外周动脉张力测量的设备。后者进一步细分为 2 个关键亚组：基于声学的设备和基于呼吸努力的设备。我们提供了性能评估文献综述，并客观比较了与睡眠临床医生相关的设备衍生指标和规格。总结了关键验证研究的研究人群详细人口统计学资料、排除标准和关键统计分析。
在可预见的未来，这些新型阻塞性睡眠呼吸暂停检测可穿戴设备可能成为无明显合并症的中重度阻塞性睡眠呼吸暂停高危患者的主要诊断工具。虽然预计会有更多的设备加入这一类别，但仍需要进行跨设备比较研究，以及在不同人群中进行独立的性能评估和结果研究。现在是睡眠临床医生深入了解这些新兴工具的时候了，以便通过适当实施和利用这些新型睡眠技术来改善以患者为中心的护理。
Chiang AA, Jerkins E, Holfinger S, et al. OSA diagnosis goes wearable: are the latest devices ready to shine?. 2024;20(11):1823-1838.
