Status:
NOT_YET_RECRUITING
PAP Systems Internal Clinical Studies (ICS)
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 to guide product development.
Detailed Description
This is an open label, prospective, randomized cross over (or single arm) study designed to support the development of new accessories for PAP devices. This generic protocol provides a framework metho...
Eligibility Criteria
Inclusion
- Participants who are employees of ResMed
- Participants shall be volunteers
- Participants willing to give written informed consent
- Participants who ≥ 18 years of age
- Participants willing and able to complete the specified tasks
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06173050
Start Date
October 1 2024
End Date
December 1 2029
Last Update
August 19 2024
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