Status:
NOT_YET_RECRUITING
PAP Systems External Clinical Studies (ECS)
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-130 years
Phase:
NA
Brief Summary
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.
Detailed Description
This is an open label, prospective, randomized cross over (or single arm) study for ongoing product development of new accessories for PAP devices. This generic protocol provides a framework methodolo...
Eligibility Criteria
Inclusion
- Participants willing to give written informed consent
- Participants who ≥ 18 years of age
- Participants being treated for OSA for ≥ 3 months
- Participants currently using a suitable PAP system(s)
- Participants who can trial the PAP systems for up to 7 nights each
- Additional criteria for remote studies:
- Participants currently using PAP device compatible with AirView, or with download capacity from PAP machine from data cards
- Participants who have access to video call equipment
Exclusion
- Participants using Bilevel flow generators
- Participants who are or may be pregnant
- Participants with a preexisting 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 medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)
- Participants who are currently enrolled in other clinical studies
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06562205
Start Date
March 1 2025
End Date
July 1 2025
Last Update
September 19 2024
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