Peer-Reviewed Publication
ERJ Open Res2026;12(3)May 1, 2026Journal Article

Clinical validation of respiratory outcomes for a patch-based polysomnography system.

Holger Woehrle1, Christian Viniol2, Wolfgang Galetke3, Georg Nilius4, Christoph Schöbel5, Winfried Randerath6, James Leiter7, Sebastian Canisius8, Hartmut Schneider9,10,11
1Lungenzentrum Ulm, Ulm, Germany.
2Universitätsklinikum Gießen und Marburg GmbH, Department of Pneumology, Marburg, Germany.
3VAMED Klinik Hagen-Ambrock, Hagen, Germany.
4Klinikum Dortmund gGmbH, University Witten-Herdecke, Dortmund, Germany.
5Universitätsmedizin Essen Ruhrlandklinik, Essen, Germany.
6Krankenhaus Bethanien, Solingen, Germany.
7Department of Molecular and Systems Biology, Geisel School of Medicine, Hanover, NH, USA.
8ACliRA Consulting ApS, Tønder, Denmark.
9American Sleep Clinic, Frankfurt, Germany.
10Onera Health, Eindhoven, Netherlands.
11Johns Hopkins University, Baltimore, MD, USA.

Abstract

STUDY OBJECTIVES: The Onera Sleep Test System (STS), the first wireless, patch-based, type II polysomnography (PSG) device designed to enable unattended sleep studies at the patient's home, has been introduced. This multicentre study validated data collected from the patch-based PSG against traditional PSG for the classification of sleep-related respiratory events. MATERIALS AND METHODS: Seven cl…

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