Evaluation of Continuous Positive Airway Pressure Mask Systems: Comparison of Cushions, Frames, Headgear, Components and Accessories for product development
- Conditions
- obstructive sleep apneaRespiratory - Sleep apnoea
- Registration Number
- ACTRN12618001407280
- Lead Sponsor
- ResMed Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
MA17082018 (2018-2023):
•Patients willing to give written informed consent
•Patients who can read and comprehend English
•Patients who >/= 18 years of age
•Patients being treated for OSA for >/= 6 months
•Patients currently using a suitable mask system
•Patients who can trial the masks for up to 7 nights each
SLP-23-04-02 (2023-2028):
•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 mask system(s)
•Participants who can trial the masks for up to 7 nights each
MA17082018 (2018-2023):
•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
•Participants 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) (for masks with magnetic clips only)
SLP-23-04-02 (2023-2028):
•Patients using Bilevel flow generators
•Patients who are 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 medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)
•Patients who are currently enrolled in other clinical studies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective mask usability including comfort, seal, and ease of use as assessed by patient questionnaire (ie. 11-point Likert scale designed for this protocol) [ After a maximum of 7 nights];Mask efficacy, as collected by Apnea-hypopnoea index downloaded by the CPAP device[ After a maximum of 7 nights]
- Secondary Outcome Measures
Name Time Method Objective mask leak as assessed by CPAP device data [ After a maximum of 7 nights]