Recruiting

CPAP

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT04217603

Conditions

Tracheobronchomalacia

Excessive Dynamic Airway Collapse

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous positive airway pressure (CPAP) device

Sham-continuous positive airway pressure (CPAP) device

Study Details

Brief summary:

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.

Conditions

Tracheobronchomalacia

Excessive Dynamic Airway Collapse

Study ID

NCT04217603

Start date

Mar 1, 2023

Status verified date

Apr, 2026

Completion date

Sep 29, 2026

Anticipated

Primary completion date

Sep 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

This group will perform a 6MWT with CPAP

sham comparator: Group 2

This group will perform a 6MWT with a sham-CPAP

Interventions

Continuous positive airway pressure (CPAP) device

Use of a CPAP during a 6 minute walk test to maintain the airways open during the respiratory cycle

Sham-continuous positive airway pressure (CPAP) device

An enlarged air leak incorporated into the exhalation valve will be positioned between the mask and the CPAP tubing, allowing airflow resistance of the exhalation port to be almost eliminated by increasing its area, thereby virtually cancelling positive pressure. Also an orifice restrictor in the CPAP circuit will be connected between the CPAP unit and the tubing in order to load the blower with the same airflow resistance as in true CPAP.

Primary outcome measure

  • Difference in meters walked in 6MWTs [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Adnan Majid, MD FCCP

617 6328252amajid@bidmc.harvard.edu

Principal Investigator:

Adnan Majid, MD FCCP

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Continuous Positive Airway Pressure
  • Tracheobronchomalacia
  • Excessive Dynamic Airway Collapse
  • Excessive Central Airway Collapse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-04-13.