- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02097212
Correlation Between Trachebroncho Malacia/Hyperdynamic Airway Collapse And Obstructive Sleep Apnea
Study Overview
Status
Detailed Description
Tracheobronchomalacia (TBM) and HyperDynamic Airway Collapse (HDAC) are two distinct airway diseases that lead to airway collapse which can in turn lead to the symptoms of dyspnea, cough, and inability to expectorate sputum effectively. TBM entails flaccid tracheal and bronchial cartilages leading to airway collapse, emanating primarily from the anterior wall of the lumen. It is seen in conditions such as Relapsing Polychondritis and saber sheath tracheal deformity. HDAC on the other hand is the hyper-flaccidity of the membranous portion of the tracheobronchial tree leading to airway collapse. This condition is commonly seen with obesity and severe emphysema. TBM and HDAC frequently coexist.
In patients with TBM/HDAC sleep disorders are common. Patients often complain of poor quality sleep, snoring, daytime fatigue, and somnolence. These patients are often diagnosed with Obstructive Sleep Apnea (OSA) upon workup.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80206
- National Jewish Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Females and males ages 18-80 years old
- Able and willing to provide written informed consent
- Existing diagnosis of TBM or HDAC or both
- No pre-existing diagnosis of OSA
- No history of reconstructive surgery of chest wall or diaphragm
Exclusion Criteria:
- Inability to provide informed consent
- Non-English speaking
- Poorly controlled congestive heart failure
- Untreated Insomnia
- Severe Coronary artery disease with active symptoms of angina
- Patient is pregnant, or plans to become pregnant in next 3 months
- Moderate to severe bronchiectasis
- Severe untreated gastroesophageal disease (GERD).
- Moderate to large hiatal hernia deemed to be atleast in part responsible for TBM/HDAC
- Airway obstruction not caused by TBM /HDAC or secondary TBM/HDAC caused by conditions such as Chronic Obstructive Pulmonary Disease (COPD).
- Active or recent (with in last one year) cancer or cancer therapy (chemotherapy, radiation therapy or surgery)
- Inability to properly perform the home sleep test
- Unreliable test data after 2 attempts
- BMI>45
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epworth Sleepiness Scale
Time Frame: Baseline
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The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness.
The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali I Musani, MD, FCCP, National Jewish Health
Publications and helpful links
General Publications
- Murgu SD, Colt HG. Tracheobronchomalacia and excessive dynamic airway collapse. Respirology. 2006 Jul;11(4):388-406. doi: 10.1111/j.1440-1843.2006.00862.x.
- Majid A, Fernandez L, Fernandez-Bussy S, Herth F, Ernst A. [Tracheobronchomalacia]. Arch Bronconeumol. 2010 Apr;46(4):196-202. doi: 10.1016/j.arbres.2009.10.011. Epub 2009 Dec 9. Spanish.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS#-2794
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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