US Development and Evaluation Study of a Patch-Based PSG System
Launched by ONERA BV · Mar 11, 2025
Trial Information
Current as of April 29, 2025
Completed
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
About Onera Bv
Onera BV is an innovative clinical trial sponsor focused on advancing healthcare through the development and commercialization of cutting-edge medical technologies. With a commitment to enhancing patient outcomes, Onera specializes in the design and execution of clinical studies that leverage data-driven insights and robust methodologies. The company collaborates with healthcare professionals and industry partners to ensure that its solutions address real-world challenges, ultimately aiming to improve the quality of care and accelerate the path to market for transformative therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
St. Louis, Missouri, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported