Status:
RECRUITING
Post Market Clinical Follow Up of ResMed Mask Systems
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .
Detailed Description
This is an open label, prospective, multi-centre, single arm study for post market clinical follow up. The study will be conducted in the home environment remotely. Eligible participants currently usi...
Eligibility Criteria
Inclusion
- Participants willing to give written informed consent
- Participants who can read and comprehend English
- Participants who ≥ 18 years of age
- Participants being treated for OSA for ≥ 6 months
- Participants currently using a suitable mask system
- Participants currently using CPAP device compatible with AirView, or with download capacity from CPAP machine from data cards
Exclusion
- Participants using Bilevel flow generators
- Participants who are or may be pregnant
- Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury.
- Participants believed to be unsuitable for inclusion by the researcher
- Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05262439
Start Date
May 26 2022
End Date
June 1 2027
Last Update
October 16 2024
Active Locations (1)
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1
Medical Affairs ResMed
Sydney, New South Wales, Australia, 2153