The growing demand for sleep studies continues to strain healthcare systems, with traditional in-lab polysomnography — comprehensive testing that monitors brain waves, oxygen levels and other key metrics — often limited in accessibility.
Onera Health’s patch-based home-polysomnography (hPSG) Sleep Test System offers a new approach to addressing these challenges. A recently published multicenter study in the Journal of Clinical Sleep Medicine validated the system’s performance, demonstrating alignment with the gold standard of in-lab polysomnography.
Onera Health, focused on advancing sleep medicine through technology, developed the Sleep Test System to simplify diagnostics. The wireless, patch-based device allows patients to undergo detailed sleep assessments in their home environment. Its four lightweight, self-applied sensors, placed on the forehead, chest, abdomen and leg, can be attached in minutes, providing comfort and reducing setup time.
The device collects sleep stage and respiratory data, delivering clinical-grade insights without the complexities of a sleep lab.
The validation study, involving 206 participants across seven clinical sites in Germany and data analysis at Johns Hopkins University, showed the Onera Sleep Test System home-polysomnography closely matched in-lab polysomnography outcomes. It effectively identified sleep stages, detected respiratory irregularities such as apneas and hypopneas and maintained scoring consistency across different users.
Onera said its landmark validation study for the Sleep Test System is one of the largest sleep diagnostic trials of the decade.
Sleep apnea, characterized by repeated interruptions in breathing during sleep, is associated with serious health risks, including hypertension, heart disease and stroke.
The multicenter study findings shed light on the system’s potential to combine accessibility and accuracy, bridging critical gaps in sleep medicine.
For healthcare providers, this innovation could meet the high demand for sleep studies, alleviating long wait times and restricted access. By enabling comprehensive diagnostics at home, the system could enhance the diagnosis of conditions like sleep apnea and insomnia while supporting remote treatment monitoring.
The Onera Sleep Test System received FDA 510(k) clearance in 2022.
Remote sleep monitoring has seen growing innovation, particularly in sleep apnea diagnostics. In 2023, the FDA cleared the Sleepiz device, a bedside contactless technology designed for continuous monitoring of vital signs during sleep, primarily targeting remote patient care.
Meanwhile the Withings Sleep Analyzer offers under-the-mattress monitoring, while Apple’s FDA-cleared watchOS 11 feature tracks breathing disruptions via wrist movements. Similarly, RingConn’s Gen 2 Smart Ring delivers wearable sleep apnea monitoring with over 90% accuracy.
While these advancements showcase the growing interest in both consumer-friendly and clinical remote sleep monitoring solutions, the Onera Sleep Test System distinguishes itself with a clinical-grade system that delivers diagnostic precision critical for sleep medicine.
Onera Health has additional studies planned to validate its system in diverse clinical settings.
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