OSA diagnosis goes wearable: are the latest devices ready to shine?

ABSTRACT

STUDY OBJECTIVES: Since 2019, the FDA has cleared nine novel obstructive sleep apnea (OSA)-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. METHODS: We collected information from PubMed, FDA clearance documents, ClinicalTrial.gov, and web sources, with direct industry input whenever feasible. RESULTS: In this "device-centered" review, we broadly categorized these wearables into two main groups those that primarily harness Photoplethysmography (PPG) data and those that do not. The former include the peripheral arterial tonometry (PAT)-based devices. The latter was further broken down into two 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. CONCLUSIONS: In the foreseeable future, these novel OSA-detecting wearables may emerge as primary diagnostic tools for patients at risk for moderate-to-severe OSA 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.