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

Completed

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

• Registration Number: NCT02097212
• Lead Sponsor: National Jewish Health

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-27
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale	Baseline	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.

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States