Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment (Mask_MRI)
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|ClinicalTrials.gov Identifier: NCT01939938|
Recruitment Status : Completed
First Posted : September 11, 2013
Results First Posted : June 14, 2017
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea (OSA)||Device: Nasal and Oronasal PAP Mask||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With Positive Airway Pressure Treatment|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939938
|United States, New York|
|Weill Cornell Center for Sleep Medicine|
|New York, New York, United States, 10065|
|Principal Investigator:||Matthew Ebben, Ph.D.||Weill Medical College of Cornell University|