
Onera Health 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 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, which is essential for physicians to make accurate diagnoses and treatment decisions in sleep medicine.
The wireless, patch-based Onera STS hPSG provides 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 comprehensive sleep assessments.
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. This evidence generation strategy reflects Onera’s dedication to advancing sleep medicine through high-quality clinical research.