N/A
N=10
Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment
Obstructive Sleep Apnea (OSA)
Bottom Line
View on ClinicalTrials.gov: NCT01939938 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: AHI — 42.3; 1.58 events per hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasal and Oronasal PAP Mask (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AHI |
42.3; 1.58 | — |
| SECONDARY MRI of Upper Airway With Opposite PAP Mask |
10 | — |
Summary
Our group has recently found that the choice of positive airway pressure mask can significantly affect the pressure required to adequately treat sleep disordered breathing. The goal of this study is to visualize the upper airway in the retropalatal and retroglossal region while using both oronasal and nasal masks with CPAP in order to investigate differences in upper airway dynamics that may occur between these two mask types.
Eligibility Criteria
Inclusion Criteria
- AHI> 30/hr
- 18-75 years of age
Exclusion Criteria
- History of claustrophobia
- History of pacemaker, nerve stimulator, or any other metal implanted device
Data sourced from ClinicalTrials.gov (NCT01939938). 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.