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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea (OSA)
• Interventions: Device: Nasal and Oronasal PAP Mask

• Registration Number: NCT01939938
• Lead Sponsor: Weill Medical College of Cornell University

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-11
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2017-02-14
• Results First Submitted QC: 2017-05-17
• Results First Posted: 2017-06-14
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• AHI> 30/hr
• 18-75 years of age

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Exclusion Criteria

• History of claustrophobia
• History of pacemaker, nerve stimulator, or any other metal implanted device

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Subjects-Nasal and Oronasal PAP Mask	Nasal and Oronasal PAP Mask	Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.

Primary Outcome Measures

Name	Time	Method
AHI	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 Outcome Measures

Name	Time	Method
MRI of Upper Airway With Opposite PAP Mask	Approximately 1 hour	MRI will be used to obtain airway measurements and the position of soft tissue elements of the oropharyngeal airway will be evaluated while positive airway pressure in introduced through the opposite mask type.

Trial Locations

Locations (1)

Weill Cornell Center for Sleep Medicine; 🇺🇸 New York, New York, United States