Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea (osa)
Treatment switch cpap mask type
Sponsor Weill Medical College of Cornell University
Start date August 2011
End date July 2013
Trial size 14 participants
Trial identifier NCT01909674, 1108011845

Summary

Our group previously conducted a study looking at the performance of three styles of positive airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we found that patients using a full-mask mask required higher positive airway pressures than patients using nasal or nasal pillows style masks to achieve successful reduction of respiratory events. In the current study we want to randomly assign patients to either nasal or full-face masks and then switch to a different mask (if nasal was originally chosen than the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the number of respiratory events change with the different mask style. We expect the number of respiratory events will increase with the use of full-face masks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Initial administration of oronasal CPAP mask
switch cpap mask type
(Experimental)
Initial administration of nasal CPAP mask
switch cpap mask type

Primary Outcomes

Measure
Comparison of the effectiveness of nasal versus oronasal CPAP masks
time frame: 3 weeks for each mask condition

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years or older - previously diagnosed with OSA - returning for PAP titrations at the Center for Sleep Medicine - CPAP and titration naive - Must have a Apnea/Hypopnea Index (AHI) of ≥ 16/hr. Exclusion Criteria: - Patients with ≥ 50% central apneas

Additional Information

Official title Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP): A Randomized Cross-over Study
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.