N/A Completed N=21 Randomized Treatment

Nasal Pillows vs. Nasal Masks at High CPAP Pressure

OSA

Source: ClinicalTrials.gov NCT01690923 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcomePrimary: AHI on Nasal Mask and Pillows Mask — 1.7; 1.9 events/hour

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

Outcome Measures

Outcome	Result	p-value
PRIMARY AHI on Nasal Mask and Pillows Mask	1.7; 1.9	—
SECONDARY Usability	8.0; 8.5	—

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)

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.