One of the largest sleep diagnostic trials of the decade demonstrates comparable performance between wireless, patch-based Onera Sleep Test System and in-lab polysomnography for sleep staging and respiratory event detection.
Our portfolio company Onera Health today announced the results of a multicenter validation study confirming the performance of its Onera Sleep Test System (STS). The study, published in the Journal of Clinical Sleep Medicine, demonstrates that the patch-based Onera STS home-polysomnography performs comparably to in-lab polysomnography (PSG) – the current gold standard – for both sleep staging and respiratory event detection.
The 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.
"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, Head of Sleep Medicine at University Hospital Marburg, Germany.
Ruben de Francisco, Founder and CEO of Onera Health: "We are thrilled with the successful completion of this comprehensive validation study. 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."
Read the full announcement on Onera's website.