Correlation Between Trachebroncho Malacia/Hyperdynamic Airway Collapse And Obstructive Sleep Apnea

NCT ID: NCT02097212

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-03-31

Brief Summary

The investigators hypothesize that there is a strong correlation between OSA and TBM/HDAC. Our hypothesis is based on the similarities in mechanism (airway collapse), symptoms (daytime and nocturnal dyspnea) predisposing conditions (obesity and neuromuscular abnormalities of the chest wall and the diaphragm), and effect of interventions (CPAP and BIPAP) in these diseases.

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.

Conditions

Trachebronchomalacia (TBM); Hyper Dynamic Airway Collapse (HDAC); Obstructive Sleep Apnea (OSA)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali I Musani, MD, FCCP

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

National Jewish Health

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16771908 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20004507 (View on PubMed)

Other Identifiers

HS#-2794

Identifier Type: -

Identifier Source: org_study_id