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Validation Study of a Patch-based PSG System
Sponsor: Onera BV
Summary
This study is a study that qualifies as "other clinical investigation" under Art. 82 MDR and §47 Abs. 3 MPDG with a CE-marked device that aims to demonstrate that the physiological signals from the Onera STS system are substantially equivalent to physiological systems recorded by traditional PSG systems. Furthermore, the study aims to identify the proportion of users who can successfully perform an overnight Onera STS study in an unsupervised home setting. The Onera STS will be used within its approved indication, and the study participants will not be subjected to additional invasive or burdensome procedures.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2022-01-21
Completion Date
2024-06-21
Last Updated
2024-04-08
Healthy Volunteers
No
Conditions
Interventions
Polysomnography
Measuring and recording multiple physiological parameters from a patient which are used by clinicians to make a decision on the diagnosis of sleep.
Locations (7)
American Sleep Clinic
Frankfurt, Frankfurt Am Main, Germany
Schlaf- u. Beatmungszentrum Ulm/Blaubeuren
Blaubeuren Abbey, Germany
Ruhrlandklinik, Zentrum für Schlaf- und Telemedizin
Essen, Germany
Evang. Kliniken Essen-Mitte
Essen, Germany
VAMED Klinik Hagen-Ambrock
Hagen, Germany
Universitätsklinikum Giessen und Marburg
Marburg, Germany
Krankenhaus Bethanien
Solingen, Germany