Using a Wrist-Worn Device Based on Peripheral Arterial Tonometry to Diagnose Obstructive Sleep Apnea: In-Laboratory and Ambulatory Validation
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STUDY OBJECTIVES: To assess the accuracy of a wrist-worn device (Watch_PAT 100) to diagnose obstructive sleep apnea in the home. DESIGN: Participants completed 2 overnight diagnostic studies with the test device: 1 night in the laboratory with concurrent polysomnography and 1 night in the home with only the Watch_PAT. The order of the laboratory and home study nights was random. The frequency of respiratory events on the PSG was quantified using indexes based on 2 definitions of hypopnea: the respiratory disturbance index (RDI) using American Academy of Sleep Medicine Task Force criteria for clinical research, also referred to as the Chicago criteria (RDI.C), and the Medicare guidelines (RDI.M). The Watch_PAT RDI (PAT RDI) and oxygen desaturation index (PAT ODI) were then evaluated against the polysomnography RDI.C and RDI.M, respectively, for both Watch_PAT diagnostic nights, yielding IN-LAB and HOME-LAB comparisons. SETTING: Sleep laboratory affiliated with a tertiary-care academic medical center. PATIENTS: 30 patients referred with suspected OSA. INTERVENTIONS: N/A. MEASUREMENTS AND RESULTS: The polysomnography and PAT measures were compared using the mean [2 SD] of the differences and the intra-class correlation coefficient (ICC). The receiver-operator characteristic curve was used to assess optimum sensitivity and specificity and calculate likelihood ratios. For the IN-LAB comparison, there was high concordance between RDI.C and PAT RDI (ICC = 0.88, mean difference 2.5 [18.9] events per hour); RDI.M and PAT ODI (ICC = 0.95, mean difference 1.4 [12.9] events per hour; and sleep time (ICC = 0.70, mean difference 7.0 [93.1] minutes) between the test device and PSG. For the HOME-LAB comparison, there was good concordance between RDI.C and PAT RDI (ICC = 0.72, mean difference 1.4 [30.1] events per hour) and RDI.M and PAT ODI (ICC = 0.80, mean difference 1.6 [26.4] events per hour) for the test device and PSG. Home studies were performed with no technical failures. CONCLUSIONS: In a population of patients suspected of having obstructive sleep apnea, the Watch_PAT can quantify an ODI that compares very well with Medicare criteria for defining respiratory events and an RDI that compares favorably with Chicago criteria for defining respiratory events. The device can be used with a low failure rate for single use in the lab and home for self-administered testing.
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When two studies evaluated the home-based PAT device against in-laboratory PSG at an AHI cutoff of ≥ 15, specificity ranged from 0.77 to 1.00 and sensitivity ranged from 0.92 to 0.96.
“When two studies evaluated the home-based PAT device against in-laboratory PSG at an AHI cutoff of ≥ 15, specificity ranged from 0.77 to 1.00 and sensitivity ranged from 0.92 to 0.96.”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [105]
Table 2 (Discussion; page not available) reports that home Watch_PAT, compared with laboratory PSG at a Chicago-criteria RDI cutoff of 15, had sensitivity 0.96 and specificity 1.00. Those values match the upper ends of the claimed ranges, but this paper reports one study and does not establish the lower ends attributed to two studies. (LLM, conf=0.88)
Experimental — accuracy not yet measuredA single study evaluated the PAT device at an AHI cutoff of ≥ 30, and reported a specificity of 0.82 (95% CI: 0.57 to 0.96) and sensitivity of 0.92 (95% CI: 0.62 to 1.00).
“A single study evaluated the PAT device at an AHI cutoff of ≥ 30, and reported a specificity of 0.82 (95% CI: 0.57 to 0.96) and sensitivity of 0.92 (95% CI: 0.62 to 1.00)”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [105]
Table 2 (DISCUSSION; page unavailable) reports sensitivity of 0.92 and specificity of 0.82 at a PSG RDI.C cutoff of 30 events per hour. The paper does not report the quoted 95% confidence intervals for those measures; the confidence-interval columns in that table are for likelihood ratios. (LLM, conf=0.87)
Experimental — accuracy not yet measuredTwo cross-over studies randomized patients to home-based PAT, and in-laboratory simultaneous PSG and PAT.
“Two cross-over studies randomized patients to home-based PAT, and in-laboratory simultaneous PSG and PAT.”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [105]
The Protocol says subjects underwent a home PAT evaluation and an in-laboratory evaluation with simultaneous PAT and PSG, with the order of the two nights randomized. It describes one study with two evaluations, not two separate cross-over studies. (LLM, conf=0.87)
Experimental — accuracy not yet measured
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- Authors
- Pittman, S. D., Ayas, N. T., MacDonald, M. M., Malhotra, A., Fogel, R. B., & White, D. P.
- Affiliations
- Brigham and Women's Hospital (US)
- Corresponding author
- White, David P.
- Venue
- Sleep
- Publisher
- Oxford University Press (OUP)
- Published
- 2004-08
- Volume
- 27
- Issue
- 5
- Pages
- 923-933
- ISSN
- 0161-8105 (ISSN-L)
- 1550-9109
- PMC
- PMC3818284
- OpenAlex
- W81278584
- Cited by
- 175
- References
- 3
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 6 · 2023: 13 · 2022: 9 · 2021: 11 · 2020: 9 · 2019: 5 · 2018: 11 · 2017: 7 · 2016: 7 · 2015: 13 · 2014: 7 · 2013: 9 · 2012: 15
- FWCI
- 4.10
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- SLEEP (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute on Aging (K23AG024837)
- National Heart, Lung, and Blood Institute (R01HL073146)
- Topics
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Keywords
- apnea, peripheral arterial tonometry, wrist-worn devices, home sleep testing, diagnostic accuracy, polysomnography comparison, respiratory disturbance index, oxygen desaturation index, hypopnea, device validation, sleep apnea screening, sensitivity and specificity, likelihood ratios
- MeSH terms
- Adult, Equipment Design, Female, Humans, Male, Manometry, Oxyhemoglobins, ROC Curve, Severity of Illness Index, Wrist, Reproducibility of Results, Body Mass Index, Polysomnography, Monitoring, Ambulatory, Sleep Apnea, Obstructive
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