Onera Health, a company focused on transforming sleep medicine and remote monitoring, has announced the publication of a multicenter validation study of its Onera Sleep Test System (STS) in the Journal of Clinical Sleep Medicine. The study demonstrates 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.
Study Details and Findings
The international multicenter study, managed by an independent Clinical Research Organization, 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. There was 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.
Expert Commentary
"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."
Impact on Sleep Disorder Diagnostics
The Onera STS system allows sleep-related respiratory events to be measured remotely, offering an alternative to traditional PSG, which requires patients to be present at a sleep disorders unit within a hospital or at a sleep center for testing. Onera Health claims that its Onera STS system allows these same tests to be carried out at home using WiFi-dependent technology.
Market Growth in Remote Monitoring
Research by GlobalData found that in 2024 the market for remote monitoring technology was estimated to have reached a value of $600m, with that figure estimated to rise to approximately $760m by the end of 2030. Additionally, GlobalData estimates the market for portable PSG systems to grow from a value of $268m, with that figure set to rise to $344m by the end of 2030.
Company Perspective
Ruben de Francisco, founder and CEO of Onera Health, added: “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 home PSG sleep test, with an accuracy that is equivalent to that of traditional in-lab PSG.”
