PAP Systems External Clinical Studies (ECS) (NCT06562205) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PAP Systems External Clinical Studies (ECS)
30 participantsStarted 2028-08-01
Plain-language summary
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.
Who can participate
Age range
18 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
(usability) Comparison of the usability of an investigational component/s of the PAP system to a comparison component/s of the PAP system and/or Criterion Score of 6
Timeframe: 6 weeks
2
(efficacy) Comparison of the investigational component/s of the PAP system efficacy (AHI) to a comparison component/s of the PAP system and/or clinically relevant data
Timeframe: 6 weeks
Trial details
NCT IDNCT06562205
SponsorResMed
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-10-01
Contact for this trial
Xueling Zhu Manager - Clinical Data and Operations