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

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.

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Key information

Conditions

Trachebronchomalacia (TBM) Apnea Bronchial Diseases Cartilage Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Dyssomnias Hyper Dynamic Airway Collapse (HDAC) Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Obstructive Sleep Apnea (OSA) Respiration Disorders Respiratory Tract Diseases Skin and Connective Tissue Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Tracheal Diseases Tracheobronchomalacia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Epworth Sleepiness Scale

Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 27, 2014
Registry last updated: Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed