A study demonstrates comparable performance between the wireless, patch-based Onera Sleep Test System and in-lab polysomnography for sleep staging and respiratory event detection.
RT’s Three Key Takeaways:
- Onera STS Matches In-Lab PSG: The study confirmed that the Onera Sleep Test System offers comparable accuracy to in-lab PSG for sleep staging and respiratory event detection.
- Validated Through Multicenter Study: Conducted across multiple international clinical sites, the study established high concordance in sleep variables and inter-scorer reliability, critical for accurate diagnoses and treatment planning.
- Addresses Diagnostic Needs: The findings support the use of the Onera STS for conducting comprehensive sleep assessments outside of traditional lab settings.
Onera Health has published a multicenter validation study in the Journal of Clinical Sleep Medicine demonstrating that its patch-based Onera Sleep Test System (STS) performs comparably to gold-standard in-lab polysomnography (PSG) for both sleep staging and respiratory event detection.
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.
“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,” says Christian Viniol, MD, PhD, lead author and head of sleep medicine at University Hospital Marburg, Germany, in a release. “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.”
This validation study is part of Onera Health’s clinical evidence generation program. 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.Â
“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,” says David P. White, MD, professor of medicine, part-time at Harvard Medical School and a member of the medical advisory board at Onera Health, in a release.
Photo caption: A woman is conducting a sleep test using the patch-based Onera STS home polysomnography system.
Photo credit: Business Wire