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

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097212
• Other study ID #: HS#-2794
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: March 27, 2017
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2017
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Hyper Dynamic Airway Collapse (HDAC)
• Obstructive Sleep Apnea (OSA)
• Shock
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Trachebronchomalacia (TBM)

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

Majid A, Fernández L, Fernández-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. Review. Spanish. — View Citation

Murgu SD, Colt HG. Tracheobronchomalacia and excessive dynamic airway collapse. Respirology. 2006 Jul;11(4):388-406. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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