Status:
COMPLETED
US Development and Evaluation Study of a Patch-Based PSG System
Lead Sponsor:
Onera BV
Conditions:
Sleep Disorder (Disorder)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 18 years and older
- Referral for a suspected sleep disorder requiring a sleep diagnostic study
Exclusion
- 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
Key Trial Info
Start Date :
August 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06881667
Start Date
August 4 2023
End Date
September 2 2024
Last Update
March 18 2025
Active Locations (2)
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1
The Sleep Disorders Center of Alabama
Birmingham, Alabama, United States, 35213
2
Clayton Sleep Institute
St Louis, Missouri, United States, 63123