Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
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|ClinicalTrials.gov Identifier: NCT01738009|
Recruitment Status : Recruiting
First Posted : November 30, 2012
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea||Other: Induction of flow limitation||Not Applicable|
The mechanisms that lead to airway closure in OSA are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea.
The investigators will test if lung volumes and low respiratory drive play a role in PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients during sleep using a thin endoscope during sleep while simultaneously measuring lung volumes, genioglossus electromyogram, and pharyngeal pressure during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B|
|Actual Study Start Date :||December 8, 2012|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Induction of flow limitation
Flow limitation will be induced by sustained reductions in continuous positive airway pressure during sleep
Other: Induction of flow limitation
- Difference in peak inspiratory flow [ Time Frame: 3 minutes ]
Measured peak inspiratory flow will be compared to predicted peak inspiratory flow during flow restricted breaths.
The time frame for the outcome will be the duration of induced flow limitation (3 minutes each) . Flow limitation will be induced several times during the night. Flow limited breaths will be averaged.
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): NCT01738009
|Contact: Pedro R Genta, MD||(617) firstname.lastname@example.org|
|Contact: Lauren B Hess, BS||(617) email@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Pedro R Genta, MD 617-732-6541 firstname.lastname@example.org|
|Contact: Lauren B Hess, BS (617) 732-8976 email@example.com|
|Sub-Investigator: Pedro R Genta, MD|
|Principal Investigator:||David A Wellman, MD||Brigham and Women's Hospital|