NCT05310708

Validation Study of a Patch-based PSG System

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Onera BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-21
• Primary completion: 2024-06-21
• Completion: 2024-06-21
• First posted: 2022-04-05
• Last updated: 2024-04-08

Locations

7 sites across 1 country: Germany