Who is eligible for clinical trial NCT04217603?

Participants must meet protocol criteria for Tracheobronchomalacia. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04217603 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-07

Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC (NCT04217603)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Beth Israel Deaconess Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (10 items).

Location: Beth Israel Deaconess Medical Center — Boston, Massachusetts

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patient with a diagnosis of ECAC either via bronchoscopy or CT Scan
Age \> 18 years
Patients that will undergo a diagnostic or therapeutic bronchoscopy as part of their standard of care
Patients with a baseline 6 MWT
Patients that have never used CPAP devices in the past

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patients with poorly-controlled respiratory comorbidities (asthma, COPD, obstructed sleep apnea, GERD, relapsing polychondritis)
No evidence for acute respiratory tract infection, or respiratory tract infection within the prior 3 weeks
Resting bradycardia (\<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
Dysrhythmia that might pose a risk during exercise or training
Any disease or condition that interferes with completion of initial or follow-up assessments
Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
Subject has an inability to walk \>140m (150 yd) in 6 minutes
Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
Subject has a known sensitivity to drugs required to perform bronchoscopy.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Beth Israel Deaconess Medical Center — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗