Nasal Pillows vs. Nasal Masks at High CPAP Pressure | NCT01690923 | Trialant
CompletedInterventionalNot ApplicableUpdated Oct 8, 2014
Nasal Pillows vs. Nasal Masks at High CPAP Pressure
Nasal Pillows at High CPAP Pressure
ClinicalTrials.gov ID
NCT01690923
Lead Sponsor
ResMedINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
20Actual
Last Update Posted
Oct 8, 2014Estimated
Start Date
Aug 2011
Primary Completion Date
Dec 2012Actual
Completion Date
Dec 2012Actual
Official Title
Nasal Pillows at High CPAP Pressure
Brief Summary
The aim of this evaluation is to test:
Whether using nasal pillows at high pressures has comparable outcomes to nasal masks
Patient mask type preferences at high pressures
OSA
Nasal mask
Pillows mask
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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)