Toward standardizing the clinical testing protocols of point-of-care devices for obstructive sleep apnea diagnosis.
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PURPOSE: In recent years, point-of-care (POC) devices, especially smart wearables, have been introduced to provide a cost-effective, comfortable, and accessible alternative to polysomnography (PSG)-the current gold standard-for the monitoring, screening, and diagnosis of obstructive sleep apnea (OSA). Thorough validation and human subject testing are essential steps in the translation of these device technologies to the market. However, every device development group tests their device in their own way. No standard guidelines exist for assessing the performance of these POC devices. The purpose of this paper is to critically distill the key aspects of the various protocols reported in the literature and present a protocol that unifies the best practices for testing wearable and other POC devices for OSA. METHODS: A limited review and graphical descriptive analytics of literature-including journal articles, web sources, and clinical manuscripts by authoritative agencies in sleep medicine-are performed to glean the testing and validation methods employed for POC devices, specifically for OSA. RESULTS: The analysis suggests that the extent of heterogeneity of the demographics, the performance metrics, subject survey, hypotheses, and statistical analyses need to be carefully considered in a systematic protocol for testing POC devices for OSA. CONCLUSION: We provide a systematic method and list specific recommendations to extensively assess various performance criteria for human subject testing of POC devices. A rating scale of 1-3 is provided to encourage studies to put a focus on addressing the key elements of a testing protocol.