Validation of a wearable medical device for automatic diagnosis of OSA against standard PSG
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Published version
Author(s)
Sanchez Gomez, Jesus
Pramono, Renard Xaviero Adhi
Imtiaz, Syed Anas
Rodriguez Villegas, Esther
Valido Morales, Agustin
Type
Journal Article
Abstract
Study objective: The objective of this study was to assess the accuracy of automatic diagnosis of obstructive sleep apnea (OSA) with a new, small, acoustic-based, wearable technology (AcuPebble SA100), by comparing it with standard type 1 polysomnography (PSG) diagnosis. Material and methods: This observational, prospective study was carried out in a Spanish hospital sleep apnea center. Consecutive subjects who had been referred to the hospital following primary care suspicion of OSA were recruited and underwent in-laboratory attended PSG, together with the AcuPebble SA100 device simultaneously overnight from January to December 2022. Results: A total of 80 patients were recruited for the trial. The patients had a median Epworth scoring of 10, a mean of 10.4, and a range of 0–24. The mean AHI obtained with PSG plus sleep clinician marking was 23.2, median 14.3 and range 0–108. The study demonstrated a diagnostic accuracy (based on AHI) of 95.24%, sensitivity of 92.86%, specificity of 97.14%, positive predictive value of 96.30%, negative predictive value of 94.44%, positive likelihood ratio of 32.50 and negative likelihood ratio of 0.07. Conclusions: The AcuPebble SA100 (EU) device has demonstrated an accurate automated diagnosis of OSA in patients undergoing in-clinic sleep testing when compared against the gold-standard reference of in-clinic PSG.
Date Issued
2024-01-19
Date Acceptance
2024-01-17
Citation
Journal of Clinical Medicine, 2024, 13 (2)
ISSN
2077-0383
Publisher
MDPI AG
Journal / Book Title
Journal of Clinical Medicine
Volume
13
Issue
2
Copyright Statement
© 2024 by the authors.
Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and
conditions of the Creative Commons
Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and
conditions of the Creative Commons
Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
License URL
Publication Status
Published
Article Number
571