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Randomized Controlled Trial
. 2025 May 1;21(5):813-823.
doi: 10.5664/jcsm.11524.

Clinical validation of a wireless patch-based polysomnography system

Christian Viniol  1 , Wolfgang Galetke  2 , Holger Woehrle  3 , Georg Nilius  4 , Christoph Schöbel  5   6 , Winfried Randerath  7 , James Leiter  8 , Sebastian Canisius  9 , Hartmut Schneider  10   11   12
Affiliations
Randomized Controlled Trial

Clinical validation of a wireless patch-based polysomnography system

Christian Viniol et al. J Clin Sleep Med. .

Abstract

Study objectives: Onera Health has developed the first wireless, patch-based, type-II polysomnography (PSG) system, the Onera Sleep Test System, to allow studies to be performed unattended at the patient's home or in any bed at a medical facility. The goal of this multicenter study was to validate data collected from the patch-based PSG to a traditional PSG for sleep staging and apnea-hypopnea index.

Methods: Simultaneous traditional PSG and patch-based PSG study data were obtained in a sleep laboratory from 206 participants with a suspected sleep disorder recruited from 7 clinical sites. Blinded, randomized scoring of the traditional PSG and patch-based PSG recordings was completed according to The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications (Version 2.6) criteria by 3 independent scorers.

Results: Concordance correlation coefficients were high between the patch-based device and traditional PSG across essential sleep and respiratory variables-total sleep time (.87); wake (.84); non-rapid eye movement (REM) (.80); non-REM sleep stage 1 (N1) (.72); non-REM sleep stage 2 (N2) (.71); non-REM sleep stage 3 (N3) (.64); REM (.80); and apnea-hypopnea index (AHI) (.94). There was substantial agreement between epoch sleep staging scored on the patch-based device and traditional PSG (average Cohen's kappa of 0.62 ± 0.13 across all scorers).

Conclusions: The patch-based type-II PSG had a similar performance on sleep staging and respiratory variables when compared to traditional PSG, thus making it possible to use the patch-based PSG for a routine PSG study. These results open the possibility of performing unattended PSG studies efficiently and accurately outside the sleep laboratory improving access to high quality sleep assessments for patients with sleep disorders.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: Validation Study of a Patch-based PSG System; URL: https://clinicaltrials.gov/study/NCT05310708; Identifier: NCT05310708.

Citation: Viniol C, Galetke W, Woehrle H, et al. Clinical validation of a wireless patch-based polysomnography system. J Clin Sleep Med. 2025;21(5):813-823.

Keywords: home PSG; polysomnography; respiratory events; sleep staging; sleep-disordered breathing.

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Conflict of interest statement

All authors have seen and approved the manuscript. Research and work for this publication was completed by the clinical research organization, Maxis Medical. H. Schneider is a contractor for Onera Health and receives compensation for his time and shareholdings in the company. H. Schneider advised on the design of the clinical trial and played a role in data interpretation. H Schneider did not recruit patients, did not participate in data collection, did not complete data analysis, and did not write the manuscript. All other authors report no conflicts of interest. The study was supported financially by Onera Health, but was independently managed by Maxis Medical Inc, Frankfurt to eliminate company bias, ensure regulatory adherence and adherence with ethical board requirements.

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