Trachebronchomalacia (TBM)NCT02097212
Correlation Between Trachebroncho Malacia/Hyperdynamic Airway Collapse And Obstructive Sleep Apnea
An observational study of Trachebronchomalacia (TBM) and Hyper Dynamic Airway Collapse (HDAC), run by National Jewish Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trachebronchomalacia (TBM), Hyper Dynamic Airway Collapse (HDAC), Obstructive Sleep Apnea (OSA)
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Trachebronchomalacia (TBM), Hyper Dynamic Airway Collapse (HDAC), Obstructive Sleep Apnea (OSA)
- Keywords
- Tracheobronchomalacia, TBM, HyperDynamic Airway Collapse, HDAC, Obstructive Sleep Apnea, OSA
- Medical subject headings
- Sleep Apnea, Obstructive, Tracheobronchomalacia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trachebronchomalacia (TBM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali I Musani, MD, FCCP, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097212
- Sponsor's protocol ID
- HS#-2794
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2014
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16771908Majid 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.
PubMed 20004507
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Trachebroncho Malacia/Hyperdynamic Airway Collapse And Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02097212
- Acronym / sponsor ID
- HS#-2794
- Conditions
- Trachebronchomalacia (TBM), Hyper Dynamic Airway Collapse (HDAC), Obstructive Sleep Apnea (OSA)
- Keywords
- Tracheobronchomalacia, TBM, HyperDynamic Airway Collapse, HDAC, Obstructive Sleep Apnea, OSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- Inability to provide informed consent
- Non-English speaking
- Poorly controlled congestive heart failure
- Untreated Insomnia
- Severe Coronary artery disease with active symptoms of angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Background: PubMed 16771908Murgu 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.
- Background: PubMed 20004507Majid 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali I Musani, MD, FCCP principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trachebronchomalacia (TBM) and Hyper Dynamic Airway Collapse (HDAC), run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epworth Sleepiness Scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02097212, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.