Internal Evaluation of Prototype Mask Systems: Comparison of Cushions, Frames, Headgear, Components and Accessories
- Conditions
- Obstructive Sleep ApneaRespiratory - Sleep apnoea
- Registration Number
- ACTRN12618001471279
- Lead Sponsor
- ResMed Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria (MA17082018)
•Participants who are employees of ResMed
•Participants who are willing to give written informed consent (signed paper copy or via DocuSign)
•Participants that are willing and able to complete the specified tasks
•Participants who are at least 18 years of age
Inclusion Criteria (SLP-23-04-02):
•Participants who are employees of ResMed
•Participants willing to give written informed consent
•Participants who > or = 18 years of age
•Participants willing and able to complete the specified tasks
Exclusion Criteria (MA17082018):
•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)
Exclusion Criteria (SLP-23-04-02):
•Participants who are or may be pregnant
•Participants with a pre-existing 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 who are unsuitable for inclusion in the opinion of the investigator
•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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A composite score of subjective mask usability (comfort, seal, ease of use) as assessed by participant questionnaires (ie. 11-point Likert scale designed for this study). . [ After maximum of 7 nights on CPAP mask]
- Secondary Outcome Measures
Name Time Method Mask leak, taken from CPAP download[ After a maximum of 7 nights on CPAP]