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

June 18, 2018 updated by: Weill Medical College of Cornell University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Center for Sleep Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All Subjects-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.
Device: Nasal and Oronasal PAP Mask
Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI of Upper Airway With Opposite PAP Mask
Time Frame: 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.
Approximately 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1207012713

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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