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Jun, 2021;25 (2): 737-748.

Toward standardizing the clinical testing protocols of point-of-care devices for obstructive sleep apnea diagnosis.

Vivek Tangudu, Kahkashan Afrin, Sandy Reddy, Nicolaas E P Deutz, Steven Woltering, Satish T S Bukkapatnam
Author Information
  1. Vivek Tangudu: Department of Industrial & Systems Engineering, Texas A&M University, 101 Bizzell St, College Station, TX, 77843, USA.
  2. Kahkashan Afrin: Department of Industrial & Systems Engineering, Texas A&M University, 101 Bizzell St, College Station, TX, 77843, USA.
  3. Sandy Reddy: Department of Biomedical Engineering, Texas A&M University, College Station, TX, 77843, USA.
  4. Nicolaas E P Deutz: Center for the Translation Research in Aging and Longevity, Human Clinical Research Facility, Texas A&M University, College Station, TX, 77843, USA.
  5. Steven Woltering: Department of Educational Psychology, Texas A&M University, College Station, TX, 77843, USA.
  6. Satish T S Bukkapatnam: Department of Industrial & Systems Engineering, Texas A&M University, 101 Bizzell St, College Station, TX, 77843, USA. satish@tamu.edu. ORCID
PMID: 32865729 DOI: 10.1007/s11325-020-02171-5

Abstract

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.

Keywords

Human subject testing Obstructive sleep apnea diagnosis Portable monitors Protocol Wearable sensor

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Grants

  1. 1543226/National Science Foundation

MeSH Term

Humans
Point-of-Care Testing
Sleep Apnea, Obstructive
Journal Article
Article has an altmetric score of 1

Word Cloud

Created with Highcharts 10.0.0testingdevicesPOCsleepOSAsubjectdiagnosisapneadeviceperformanceprotocolpoint-of-careprovideobstructivevalidationhumankeyvariousprotocolsclinicalsystematicPURPOSE:recentyearsespeciallysmartwearablesintroducedcost-effectivecomfortableaccessiblealternativepolysomnographyPSG-thecurrentgoldstandard-formonitoringscreeningThoroughessentialstepstranslationtechnologiesmarketHowevereverydevelopmentgrouptestswaystandardguidelinesexistassessingpurposepapercriticallydistillaspectsreportedliteraturepresentunifiesbestpracticeswearableMETHODS:limitedreviewgraphicaldescriptiveanalyticsliterature-includingjournalarticleswebsourcesmanuscriptsauthoritativeagenciesmedicine-areperformedgleanmethodsemployedspecificallyRESULTS:analysissuggestsextentheterogeneitydemographicsmetricssurveyhypothesesstatisticalanalysesneedcarefullyconsideredCONCLUSION:methodlistspecificrecommendationsextensivelyassesscriteriaratingscale1-3providedencouragestudiesputfocusaddressingelementsTowardstandardizingHumanObstructivePortablemonitorsProtocolWearablesensor

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