CPAP for Excessive Dynamic Airway Collapse
Trial Summary
What is the purpose of this trial?
The purpose of this protocol is to perform a prospective, randomized, double-blinded, pacebo-controlled clinical trial to determine the influence of a non-invasive positive pressure ventilation device on exercise capacity and symptoms in adult patients with ECAC. Primary outcome will include the total distance traversed by the study subject during a standard 6-minute walk test, and secondary outcomes will include peak flow measurement and symptom reporting before and after the exercise testing. The study will focus on the use of continuous positive airway pressure (CPAP) device. CPAP is FDA-approved for the treatment of various medical conditions, including obstructive sleep apnea and heart failure, but is not FDA-approved for the treatment of ECAC. The study will enroll 32 ambulatory study subjects with confirmed ECAC at the BIDMC, and each study subject will be monitored for up to 3 months.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have poorly-controlled respiratory conditions or certain heart issues, you may not be eligible to participate.
What data supports the effectiveness of the treatment Continuous Positive Airway Pressure (CPAP) for Excessive Dynamic Airway Collapse?
Is CPAP generally safe for humans?
How is CPAP treatment unique for excessive dynamic airway collapse?
CPAP treatment is unique because it provides continuous air pressure to keep the airways open, which can help prevent the need for more invasive procedures like intubation. Unlike other treatments, CPAP is non-invasive and can be used at home, making it a convenient option for managing airway issues.45101112
Eligibility Criteria
Adults over 18 with ECAC confirmed by bronchoscopy or CT scan, who can walk more than 140m in six minutes and have never used CPAP devices. Excluded are those with conditions affecting the trial's assessments, poorly-controlled respiratory issues, recent infections, certain heart rhythm problems, sensitivity to sedation drugs for bronchoscopy, or severe physical limitations not related to breathing.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial evaluation including PFTs, 6MWT, dynamic CT scan, and bronchoscopy to confirm ECAC diagnosis
Treatment
Participants undergo CPAP calibration and perform 6MWT with either CPAP or sham-CPAP
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Continuous positive airway pressure (CPAP) device
- Sham-continuous positive airway pressure (CPAP) device
Continuous positive airway pressure (CPAP) device is already approved in United States, European Union, Canada for the following indications:
- Obstructive Sleep Apnea
- Heart Failure
- Obstructive Sleep Apnea
- Heart Failure
- Respiratory Failure
- Obstructive Sleep Apnea
- Heart Failure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor