Status:
ENROLLING_BY_INVITATION
Validation Study of a Patch-based PSG System
Lead Sponsor:
Onera BV
Conditions:
Sleep Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 On...
Eligibility Criteria
Inclusion
- 18 years and older
- Either referral for a suspected sleep disorder requiring a sleep diagnostic study, or,
- An already diagnosed sleep disorder requiring a planned follow-up PSG.
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 :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 21 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05310708
Start Date
January 21 2022
End Date
June 21 2024
Last Update
April 8 2024
Active Locations (7)
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1
American Sleep Clinic
Frankfurt, Frankfurt Am Main, Germany, 60389
2
Schlaf- u. Beatmungszentrum Ulm/Blaubeuren
Blaubeuren Abbey, Germany, 89143
3
Ruhrlandklinik, Zentrum für Schlaf- und Telemedizin
Essen, Germany, 45239
4
Evang. Kliniken Essen-Mitte
Essen, Germany, 45276