CompletedNot Applicable

PEEP Mask for Tracheobronchomalacia-Induced Cough

United States10 participantsStarted 2021-08-30

Plain-language summary

This study aims to determine if an expiratory resistance device that delivers non-invasive positive expiratory pressure (nPEP) will reduce or stop coughing, reduce airway resistance and improve quality of life in patients with tracheobronchomalacia (TBM) who are not candidates for tracheal stenting.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * Visualization of ≥50% collapse of the trachea or mainstem bronchus on CT scan or bronchoscopy * No upper or lower respiratory infection within 4 weeks * Having capacity to provide legal written informed consent Exclusion Criteria: * History of tracheobronchoplasty or chronic tracheal stenting * Current tracheostomy * History of external chest trauma * History of: * Active treatment for Lung cancer * Lung transplantation * Unstable congestive heart failure * History of spontaneous pneumothorax * Other medical conditions that interfere with participation in the study * Pregnant women

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Cough Severity as Measured by the Cough Visual Analog Scale (VAS)

Timeframe: Baseline, two weeks

Change in Quality of Life as Measured by the Cough-Specific Quality-of-Life Questionnaire (CQLQ)

Timeframe: Baseline, two weeks

Change in Quality of Life as Measured by the Leicester Cough Questionnaire (LCQ)

Timeframe: Baseline, two weeks

Trial details

NCT IDNCT04169282

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-15

Results submitted2023-07-25

View on ClinicalTrials.gov More Tracheobronchomalacia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Cough Severity as Measured by the Cough Visual Analog Scale (VAS)

Timeframe: Baseline, two weeks

Change in Quality of Life as Measured by the Cough-Specific Quality-of-Life Questionnaire (CQLQ)

Timeframe: Baseline, two weeks

Change in Quality of Life as Measured by the Leicester Cough Questionnaire (LCQ)

Timeframe: Baseline, two weeks