US Development and Evaluation Study of a Patch-Based PSG System

Completed · Not applicable

Conditions studied: Sleep Disorder (Disorder)

In brief

The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.

Key facts

Study ID

NCT06881667

Run by

Onera BV

People needed

70

Starts

2023-08-04

Expected to finish

2024-09-02

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years and older
• Referral for a suspected sleep disorder requiring a sleep diagnostic study

You may not qualify if…

• Inability to provide informed consent
• History of allergic reactions to adhesives or hydrogels or a family history of adhesive skin allergies
• Severe skin condition at sites of patch administration such as wounds, burns or on any damaged skin
• Has an implanted cardiac stimulator or diaphragmatic pacer
• Has an anatomical abnormality that, in the opinion of the Principal Investigator, makes the subject ineligible for inclusion
• Will be exposed to high-frequency surgical equipment, near strong magnetic fields or with devices such as MRIs, external cardiac stimulators during their use of the Onera device

Where it is running

• The Sleep Disorders Center of Alabama — Birmingham, Alabama, United States
• Clayton Sleep Institute — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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