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ENROLLING BY INVITATION
NCT05310708
NA

Validation Study of a Patch-based PSG System

Sponsor: Onera BV

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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