Obstructive Sleep Apnea disease burden in patients with intolerance to positive airway pressure therapy–results from a pilot study

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Heiser C et al.

The study utilized the patch-based self-applied polysomnography system Onera STS, to collect objective sleep data from patients with Obstructive Sleep Apnea (OSA) who are intolerant or unable to use positive airway pressure (PAP) therapy. The Onera STS device enabled the researchers to gather valuable information on the disease burden and sleep characteristics of these patients, contributing to the assessment of the unmet medical need  in this population.

Doi: 10.1007/ s11818- 024-00486-z

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FDA 510k cleared and CE-marked refers to the Onera Sleep Test System, which is a Class IIa medical device. Onera STS includes the Onera STS I System, which is CE marked in Europe, and the Onera STS System, which was cleared the the Food and Drug Administration for use in the United States.
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