Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment
Mask_MRI
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 13, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedJuly 17, 2018
June 1, 2018
1.8 years
August 13, 2013
February 14, 2017
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
AHI
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 Outcomes (1)
MRI of Upper Airway With Opposite PAP Mask
Approximately 1 hour
Study Arms (1)
All Subjects-Nasal and Oronasal PAP Mask
EXPERIMENTALEach 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.
Interventions
Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20.
Eligibility Criteria
You may qualify if:
- AHI\> 30/hr
- years of age
You may not qualify if:
- History of claustrophobia
- History of pacemaker, nerve stimulator, or any other metal implanted device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Center for Sleep Medicine
New York, New York, 10065, United States
Related Publications (1)
Ebben MR, Milrad S, Dyke JP, Phillips CD, Krieger AC. Comparison of the upper airway dynamics of oronasal and nasal masks with positive airway pressure treatment using cine magnetic resonance imaging. Sleep Breath. 2016 Mar;20(1):79-85. doi: 10.1007/s11325-015-1187-x. Epub 2015 Apr 30.
PMID: 25924934DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Matthew Ebben
- Organization
- Weill Cornell Medical College
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Ebben, Ph.D.
Weill Medical College of Cornell University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2013
First Posted
September 11, 2013
Study Start
June 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
July 17, 2018
Results First Posted
June 14, 2017
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share