Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment
Completed · Not applicable
Conditions studied: Obstructive Sleep Apnea (OSA)
In brief
This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites). Each participant will use the investigational PAP device with their own mask for a period of up to 7 nights and will complete a series of questionnaires upon completion. The study will evaluate the usability and efficacy of the investigational device in the intended use environment by the intended use population.
Key facts
- Study ID
- NCT04744038
- Run by
- ResMed
- People needed
- 108
- Starts
- 2020-08-12
- Expected to finish
- 2021-03-05
- Last updated by the study team
- 2021-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients who ≥ 18 years of age
- Patients being established on PAP therapy for the treatment of OSA for ≥ 6 months
- Patients currently using AirSense10 (as their primary device)
- Patients currently using an appropriate mask system (AirFit F20, AirFit P10, AirFit N20, AirFit N30i, AirFit F30i or AirFit P30i)
- Patients who can trial the investigational device for up to 7 nights
- Patients who have been compliant to therapy (average of ≥4 hours of usage) for the previous 7 nights of use* *the most recent consecutive 7 nights within the last 30 days
You may not qualify if…
- Patients using Bilevel flow generators
- Patients who are or may be pregnant
- Patients 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.
- Patients believed to be unsuitable for inclusion by the researcher
- Patients 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)
- Patients using supplemental oxygen
Where it is running
- Sleep Data — San Diego, California, United States
- ResMed BELLA VISTA — Sydney, New South Wales, Australia
Full record on ClinicalTrials.gov
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