N/A
N=21
Nasal Pillows vs. Nasal Masks at High CPAP Pressure
OSA
Bottom Line
View on ClinicalTrials.gov: NCT01690923 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: AHI on Nasal Mask and Pillows Mask — 1.7; 1.9 events/hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasal mask (Device); Pillows mask (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AHI on Nasal Mask and Pillows Mask |
1.7; 1.9 | — |
| SECONDARY Usability |
8.0; 8.5 | — |
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
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01690923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.