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Clinical Trials/NCT01909674
NCT01909674
Completed
Not Applicable

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

Weill Medical College of Cornell University1 site in 1 country21 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea (OSA)
Sponsor
Weill Medical College of Cornell University
Enrollment
21
Locations
1
Primary Endpoint
Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
August 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks

Time Frame: 3 weeks for each mask condition

Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.

Study Sites (1)

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