Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
Recruitment status was Recruiting
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B|
- Difference in peak inspiratory flow [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
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.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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|
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).
Please refer to this study by its ClinicalTrials.gov identifier: 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|