Peer-Reviewed Publication
J Clin Sleep Med2025;21(5):813-823.May 1, 2025Journal Article

Clinical validation of a wireless patch-based polysomnography system.

Christian Viniol1, Wolfgang Galetke2, Holger Woehrle3, Georg Nilius4, Christoph Schöbel5,6, Winfried Randerath7, James Leiter8, Sebastian Canisius9, Hartmut Schneider10,11,12
1Department of Pneumology, Universitätsklinikum Gießen und Marburg GmbH, Marburg, Germany.
2VAMED Klinik Hagen-Ambrock, Hagen, Germany.
3Lungenzentrum Ulm, Ulm, Germany.
4Klinikum Dortmund gGmbH, Dortmund, Germany.
5Department of Pneumology, Universitätsmedizin Essen Ruhrlandklinik, Essen, Germany.
6Faculty of Sleep and Telemedicine, Universitätsmedizin Essen Ruhrlandklinik, Essen, Germany.
7Krankenhaus Bethanien, Solingen, Germany.
8Department of Molecular and Systems Biology, Geisel School of Medicine, Hanover, New Hampshire.
9ACliRA Consulting ApS, Tønder, Denmark.
10American Sleep Clinic, Frankfurt, Germany.
11Onera Health, Eindhoven, Netherlands.
12Johns Hopkins University, Baltimore, Maryland.

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 ind…

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