New Clinical Study Publication Validates Respiratory Outcomes for the Onera Home-polysomnography System

Onera Health, a leader in transforming sleep medicine, announces the recent publication of a multicenter validation study of its Onera Sleep Test System (STS) in the ERJ Open Research, a leading, fully open-access scientific journal published by the European Respiratory Society (ERS). This is the second publication from this study, and it demonstrates that the patch-based Onera STS home-polysomnography (hPSG) device accurately identifies respiratory events and distinguishes AHI severity when validated against simultaneous in-lab polysomnography and is a viable option for unattended home use.

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The international multicenter study was managed by an independent Clinical Research Organization and involved the analysis of 206 participants across seven clinical sites in Germany and a US-based core laboratory at Johns Hopkins University. As detailed in the first publication, the study found high concordance between the Onera STS and traditional PSG across essential sleep variables and key respiratory parameters, as well as substantial epoch-by-epoch agreement in sleep staging and comparable inter-scorer reliability between the two systems, which is essential for physicians to make accurate diagnoses and treatment decisions in sleep medicine. This publication extends those findings to include accurately identifying respiratory events and distinguishing AHI severity when validated against simultaneous in-lab polysomnography, further validating the Onera STS as a viable option for unattended home use.

"We are very pleased to have further validation of the utility of Onera STS in accurately identifying respiratory events and distinguishing AHI severity,” said Ruben de Francisco, Founder and CEO of Onera Health. "This comprehensive validation study further demonstrates that our innovative, patch-based technology can deliver the level of accuracy needed for a comprehensive hPSG sleep test, with an accuracy that is equivalent to that of traditional in-lab PSG for all relevant clinical parameters. This publication further supports our mission to make the gold-standard sleep test, polysomnography or PSG, available at the patient’s home.”

"These additional results from the Onera STS validation study further demonstrate the diagnostic value of high-quality sleep assessment in the patient's natural environment. The ability to achieve results from home PSG testing that are equivalent to in-lab PSG will help remove the barriers to access created by resource limitations thus providing accurate diagnosis to significantly more patients suffering from under or undiagnosed sleep disorders,” added Dr. David P. White, Harvard Medical School, Boston, United States, and Member of the Medical Advisory Board at Onera Health.

This landmark validation study is part of Onera Health's comprehensive clinical evidence generation program, demonstrating the commitment to rigorous scientific validation of Onera’s technology. Additional studies are currently ongoing across multiple centers and healthcare settings, which will further validate the clinical utility and real-world impact of Onera’s home Polysomnography solution. This evidence generation strategy reflects Onera’s dedication to advancing sleep medicine through high-quality clinical research.

This study publication, entitled 'Clinical validation of respiratory outcomes for a patch-based polysomnography system', is published in the ERJ Open Research journal published by the European Respiratory Society (ERS) and can be accessed online at https://publications.ersnet.org/content/erjor/early/2025/12/04/2312054100857-2025https://doi.org/10.1183/23120541.00857-2025.

The first publication from this study entitled 'Clinical validation of a wireless patch-based polysomnography system', was published in the Journal of Clinical Sleep Medicine and can be accessed online at https://doi.org/10.5664/jcsm.11524

About Onera

Onera Health is a leader in transforming sleep medicine and remote monitoring. Their breakthrough diagnostic solutions and services are poised to help millions of people struggling with sleep-related ailments while also impacting other medical fields by monitoring various chronic conditions, ultimately improving the health and quality of life of patients worldwide. The company’s innovative solutions provide comprehensive sleep test data to physicians in a variety of clinical and non-clinical environments to optimize patient care and reduce healthcare costs. Onera has offices in the Netherlands and the U.S. For more information, go to onerahealth.com

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