Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D
|ClinicalTrials.gov Identifier: NCT01733784|
Recruitment Status : Unknown
Verified September 2013 by David Andrew Wellman, Brigham and Women's Hospital.
Recruitment status was: Recruiting
First Posted : November 27, 2012
Last Update Posted : September 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea||Other: Induced central apneas||Not Applicable|
In obstructive sleep apnea, the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure 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 how the viscoelastic properties of the airway influence PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients using a thin endoscope and will induce central apneas during sleep. Pharyngeal cross-sectional area will be recorded during incremental changes in pharyngeal pressure during central apneas.
|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 D|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
|Experimental: Viscoelastic properties of the airway||Other: Induced central apneas|
- Upper airway elasticity [ Time Frame: 10 - 40 seconds ]
The investigators will determine elasticity of the upper airway during induced central apneas by dividing the change in airway pressure by the change in airway cross-sectional area.
The time frame for the outcome of this study is equal to the duration of the induced central sleep apnea (usually less than 40 seconds).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733784
|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|