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

Launched by ONERA BV · Mar 11, 2025

Keywords

ClinConnect Summary

The diagnostic gold standard to detect a sleep disorder in the presence of a comorbidity is attended, inpatient, polysomnography (PSG)1. Currently, these tests are limited to the in-patient setting in the sleep laboratory, which requires a large number of personnel, and the PSG studies are time-consuming and expensive to conduct. PSG studies are also burdensome for patients, as they require each patient to sleep at the hospital for at least one night while wearing multiple electrodes and other physiological monitoring equipment attached to the head, face, torso, and legs, which makes sleepi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years and older
• • Referral for a suspected sleep disorder requiring a sleep diagnostic study
• Exclusion Criteria:
• • 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