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

Brief Title

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

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

Epworth Sleepiness Scale


Condition

Trachebronchomalacia (TBM)



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1

Start Date

March 2014

Completion Date

March 2015

Primary Completion Date

March 2015

Eligibility 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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Ali I Musani, MD, FCCP, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02097212

Organization ID

HS#-2794


Responsible Party

Sponsor

Study Sponsor

National Jewish Health


Study Sponsor

Ali I Musani, MD, FCCP, Principal Investigator, National Jewish Health


Verification Date

March 2017