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

Obstructive Sleep Apnea (OSA) Clinical Trial

— Mask_MRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939938
• Other study ID #: 1207012713
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea (OSA)
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Center for Sleep Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MRI of Upper Airway With Opposite PAP Mask	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