Landmark Clinical Study Validates Patch-Based Onera Home-Polysomnography System in One of the Largest Sleep Diagnostic Trials of the Decade

Study demonstrates comparable performance between wireless, patch-based Onera Sleep Test System and in-lab polysomnography for sleep staging and respiratory event detection.

Onera Health, a leader in transforming sleep medicine and remote monitoring, today announced the publication of a multicenter validation study of its Onera Sleep Test System (STS) in the Journal of Clinical Sleep Medicine, the official journal of the American Academy of Sleep Medicine. The study demonstrated that the patch-based Onera STS home-polysomnography (hPSG) performs comparably to gold-standard in-lab polysomnography (PSG) for both sleep staging and respiratory event detection.

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A woman is conducting a sleep test (polysomnography) using the patch-based Onera STS hPSG system. (Photo: Business Wire)

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. 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.

"Our rigorous multicenter validation study provides robust evidence that the Onera Sleep Test System performs comparably to traditional in-lab polysomnography for sleep staging and respiratory event detection," said Dr. Christian Viniol, MD, Ph. D, lead author and Head of Sleep Medicine at University Hospital Marburg, Germany. "This validation is crucial as we face increasing demand for sleep studies alongside increasing resource constraints. The proven accuracy of Onera’s product will significantly improve access to comprehensive sleep diagnostics, potentially transforming our approach to diagnosing and treating sleep disorders on a larger scale."

"We are thrilled with the successful completion of this comprehensive validation study," said Ruben de Francisco, Founder and CEO of Onera Health. "This validation is a critical milestone in our mission to make the gold-standard sleep test, polysomnography or PSG, available at the patient’s home. The results clearly demonstrate 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."

"These results represent an important milestone in our journey toward more accessible and personalized sleep medicine. The Onera technology enables high-quality sleep assessment in the patient's natural environment, opening new possibilities for longitudinal monitoring and improved assessment of treatment outcomes. This capability may fundamentally transform the future of sleep disorder diagnosis and treatment evaluation in the future," added Dr. David P. White, Professor of Medicine, Part Time at Harvard Medical School, Boston, United States, and Member of the Medical Advisory Board at Onera Health.

The wireless, patch-based Onera STS hPSG addresses critical challenges in sleep medicine by providing a viable alternative to traditional in-lab polysomnography. Its comparable performance in sleep staging and respiratory event detection, coupled with simplified application, significantly increases access to high-quality, comprehensive sleep assessments.

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.

The study, entitled 'Clinical validation of a wireless patch-based polysomnography system', is published in the Journal of Clinical Sleep Medicine and can be accessed online at https://jcsm.aasm.org/doi/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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