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.

Study Overview

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

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: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In this pilot study we plan to recruit 30 consecutive patients with TBM/HDAC from the interventional pulmonology clinic at National Jewish Health (NJH). These patients will already have an established diagnosis of TBM and/or HDAC.

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Scale	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.	Baseline

Collaborators and Investigators

• Sponsor: National Jewish Health
• 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: March 1, 2014
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (ESTIMATE): March 27, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: OSA; Obstructive Sleep Apnea; Tracheobronchomalacia; HDAC; TBM; HyperDynamic Airway Collapse
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Shock
• Other Study ID Numbers: HS#-2794