Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C
|ClinicalTrials.gov Identifier: NCT01738022|
Recruitment Status : Unknown
Verified September 2013 by David Andrew Wellman, Brigham and Women's Hospital.
Recruitment status was: Recruiting
First Posted : November 30, 2012
Last Update Posted : September 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea||Other: Administration of gas mixtures||Not Applicable|
Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models.
In this study, subjects will breathe gas mixtures of different densities (helium and sulfur-hexafluoride) or viscosity (neon) for brief periods of time during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP). The investigators will test some models of upper airway collapse by observing if flow while breathing different gas mixtures scales according to the differences in density and viscosity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: Gas mixture administration
Subjects will breathe different gas mixtures with different densities and viscosity for brief periods in order to promote changes in peak inspiratory flow
Other: Administration of gas mixtures
- Difference in peak inspiratory flow [ Time Frame: 10 - 15 seconds ]
Observed peak inspiratory flow while breathing different gas mixtures will be compared to model predicted flows.
Subjects will breathe different gas mixtures for 2 consecutive breaths only. Therefore the time frame is equal to one breath before gas mixture administration and two breaths after (usually 10-15 seconds).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738022
|Contact: Pedro R Genta, MD||(617) email@example.com|
|Contact: Lauren B Hess, BS||(617) firstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Sub-Investigator: Pedro R Genta, MD|
|Principal Investigator:||David A Wellman, MD||Brigham and Women's Hospital|