Status:
COMPLETED
Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea (OSA)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 PA...
Detailed Description
A new PAP device has been developed by ResMed which includes an improved humidification system, a new user interface and optimized workflows. This study will assess the efficacy and usability of the n...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04744038
Start Date
August 12 2020
End Date
March 5 2021
Last Update
July 13 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sleep Data
San Diego, California, United States, 92123
2
ResMed BELLA VISTA
Sydney, New South Wales, Australia, 2153