PAP Systems External Clinical Studies (ECS)
ConditionObstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-130
SponsorResMed
About this trial
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- PAP System A (with Amalfi) then PAP System B (with CLA11)
- PAP System B (with CLA11) then PAP System A (with Amalfi)
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov