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Clinical Trials/NCT01939938
NCT01939938
Completed
Not Applicable

Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With Positive Airway Pressure Treatment

Weill Medical College of Cornell University1 site in 1 country10 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea (OSA)
Sponsor
Weill Medical College of Cornell University
Enrollment
10
Locations
1
Primary Endpoint
AHI
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Detailed Description

It is known that oronasal masks are not as effective at opening the upper airway compared to nasal only continuous positive airway pressure (CPAP) masks in patients with sleep-disordered breathing. However, the physiological mechanism for this difference in efficacy is not known; although, it has been hypothesized to involve the retroglossal and/or retropalatal region of the upper airway. The objective of this study was to investigate differences in retroglossal and retropalatal anterior-posterior space with the use of oronasal vs. nasal CPAP masks using real-time cine magnetic resonance imaging (cMRI).

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
April 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

AHI

Time Frame: through study completion, an average of 1 hour

The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour.

Secondary Outcomes

  • MRI of Upper Airway With Opposite PAP Mask(Approximately 1 hour)

Study Sites (1)

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