Dutch remote monitoring and sleep aid company, Onera Health’s wireless, patch-based, type-II home-polysomnography system has proven to be as beneficial as in-hospital testing in a validation study.
In what the company is calling one of the largest sleep diagnostic trials of the decade, (NCT05310708) Onera found its Sleep Test System (STS) to be comparable to the industry standard of in-lab polysomnography (PSG) for both sleep staging and respiratory event detection.
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Published in the Journal of Clinical Sleep, the validation study examined the company’s remote monitoring alternative to measuring sleep-related respiratory events, as opposed to traditional PSG treatment that requires patients to be present at a sleep disorders unit within a hospital or at a sleep centre for testing. Onera Health claims that its Onera STS system allows these same tests to be carried out at home using WiFi-dependent technology.
The trial enrolled 206 patients at seven sites across the US and Germany, finding high concordance between the Onera STS and traditional PSG across essential sleep variables and key respiratory parameters.
Christian Viniol, lead author of the study, said: “Our rigorous multi-centre validation study provides robust evidence that the Onera STS performs comparably to traditional in-lab polysomnography for sleep staging and respiratory event detection.
“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.”
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By GlobalDataResearch 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.
GlobalData is the parent company of Clinical Trials Arena.
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.”
Elsewhere in the world of sleep and sleep studies, Alkermes has commenced the Phase II Vibrance-2 clinical trial of ALKS 2680 in adults with type 2 narcolepsy. Meanwhile, the UK’s National Institute for Health and Care Excellence (NICE) has recommended Acurable’s wearable AcuPebble device to support the remote diagnosis of obstructive sleep apnoea.
