Validation of a Wearable Medical Device for Automatic Diagnosis of OSA against Standard PSG

Jesus Sanchez Gomez; Renard Xaviero Adhi Pramono; Syed Anas Imtiaz; Esther Rodriguez-Villegas; Agustin Valido Morales

doi:10.3390/jcm13020571

Validation of a Wearable Medical Device for Automatic Diagnosis of OSA against Standard PSG

J Clin Med. 2024 Jan 19;13(2):571. doi: 10.3390/jcm13020571.

Authors

Jesus Sanchez Gomez¹, Renard Xaviero Adhi Pramono², Syed Anas Imtiaz², Esther Rodriguez-Villegas², Agustin Valido Morales¹

Affiliations

¹ Sleep Unit, Pneumology Department, Virgen Macarena University Hospital, 41009 Seville, Spain.
² Wearable Technologies Lab, EEE Department, Imperial College London, London SW7 2AZ, UK.

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.

Keywords: AHI; ODI; OSA; PSG; hsat; sleep; sleep apnea; sleep testing; wearable.

Grants and funding

This research received no specific funding in the form of a grant from any funding agency in the public, commercial, or not-for-profit sectors. The objective of this study was part of Acurable’s post-market surveillance plan as required by the EU Medical Device Directive 93/42 for the purpose of CE marking. Hence, as per the definition of the Directive, the study was sponsored by Acurable Limited, which covered only the hospital costs associated with it. The authors would like to thank Imperial College London Open Access Fund for paying the open access fee.