Validation Study of a Patch-based PSG System

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05310708
Study type	Interventional
Source	Onera BV
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	January 21, 2022
Completion date	June 21, 2024

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