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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02097212

Enrollment

Registered

2014-03-27

Start date

2014-03-31

Completion date

2015-03-31

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Tracheobronchomalacia, TBM, HyperDynamic Airway Collapse, HDAC, Obstructive Sleep Apnea, OSA

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results