Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02097212
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Jewish Health

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Trachebronchomalacia (TBM) Hyper Dynamic Airway Collapse (HDAC) Obstructive Sleep Apnea (OSA)

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Trachebroncho Malacia/Hyperdynamic Airway Collapse And Obstructive Sleep Apnea
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock Sleep Apnea

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097212


Locations
Layout table for location information
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Investigators
Layout table for investigator information
Principal Investigator: Ali I Musani, MD, FCCP National Jewish Health
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT02097212    
Other Study ID Numbers: HS#-2794
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Keywords provided by National Jewish Health:
Tracheobronchomalacia
TBM
HyperDynamic Airway Collapse
 HDAC
Obstructive Sleep Apnea
OSA
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Shock
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes