Nasal Pillows vs. Nasal Masks at High CPAP Pressure
Not Applicable
Completed
- Conditions
- OSA
- Registration Number
- NCT01690923
- Lead Sponsor
- ResMed
- Brief Summary
The aim of this evaluation is to test:
1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks
2. Patient mask type preferences at high pressures
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients being treated for OSA for >6 months
- Patients ≥ 18 years of age
- Patients using nasal mask systems with fixed pressure ≥ 12 cm H2O
- Patients who can trial the trial masks up to 14 nights
- Patients naive to pillows mask systems
Exclusion Criteria
- Patients using an inappropriate mask system
- Patients using Bilevel flow generators
- Patients who are pregnant
- Patients who have 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method AHI on Nasal Mask and Pillows Mask 7 days AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour
- Secondary Outcome Measures
Name Time Method Usability After 7 days of use Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)
Trial Locations
- Locations (1)
ResMed
🇦🇺Sydney, New South Wales, Australia
ResMed🇦🇺Sydney, New South Wales, Australia