Toward standardizing the clinical testing protocols of point-of-care devices for obstructive sleep apnea diagnosis
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SLEEP BREATHING PHYSIOLOGY AND DISORDERS • ORIGINAL ARTICLE
Toward standardizing the clinical testing protocols of point-of-care devices for obstructive sleep apnea diagnosis Vivek Tangudu 1 & Kahkashan Afrin 1 & Sandy Reddy 2 & Nicolaas E.P. Deutz 3 & Steven Woltering 4 & Satish T. S. Bukkapatnam 1,2 Received: 19 April 2020 / Revised: 4 August 2020 / Accepted: 12 August 2020 # Springer Nature Switzerland AG 2020
Abstract Purpose In recent years, point-of-care (POC) devices, especially smart wearables, have been introduced to provide a costeffective, 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. Keywords Obstructive sleep apnea diagnosis . Portable monitors . Wearable sensor . Protocol . Human subject testing
Introduction Presentation at a conference: None Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11325-020-02171-5) contains supplementary material, which is available to authorized users. * Satish T. S. Bukkapatnam [email protected] 1
Department of Industrial & Systems Engineering, Texas A&M University, 101 Bizzell St, College Station, TX 77843, USA
2
Department of Biomedical Engineering, Texas A&M University, College Station, TX 77843, USA
3
Center for the Translation Research in Aging and Longevity, Human Clinical Research Facility, Texas A&M University, College Station, TX 77843, USA
4
Department of Educational Psychology, Texas A&M University, College Station, TX 77843, USA
Obstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent cessations of breathing. Patients regularly report functio
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