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

NCT04217603 | Recruiting DMC FDA Device

• 1 other identifier: 2019P001034
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Difference in meters walked in 6MWTs

  Statistical difference between the 6 MWT results of the CPAP and sham-CPAP groups as compared with the initial results of the 6 MWT and between groups using ANCOVA.

  3 months

Secondary Outcomes (3)

• Modified Borg scale scores for dyspnea

  3 months

• Modified Borg scale scores for exertion

  3 months

• Subjective assestment of cough during 6MWTs

  3 months

Study Arms (2)

Group 1

EXPERIMENTAL

This group will perform a 6MWT with CPAP

Device: Continuous positive airway pressure (CPAP) device

Group 2

SHAM COMPARATOR

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

Device: Sham-continuous positive airway pressure (CPAP) device

Interventions

Continuous positive airway pressure (CPAP) device DEVICE

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

Group 1

Sham-continuous positive airway pressure (CPAP) device 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.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Tracheobronchomalacia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Respiratory Tract Diseases; Tracheal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization will be stratified using the variables sex (Female and male) and age (\<60 and \>60). Additionally a block 2-4 pattern will be used to assure a random and evenly distributed patient population in the different strata. Randomization will be carried out by the research coordinator; the rest of the personnel will be blinded to the allocation of the patients to the different groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of Interventional Pulmonology

Model Details: This prospective, randomized placebo controlled, double-blind clinical trial will be conducted at Beth Israel Deaconess Medical Center (BIDMC) in accordance with Good Clinical Practice Standards and under IRB supervision. We plan to enroll a total of 32 patients with ECAC randomized by an opaque envelope technique into two different groups: group 1 (CPAP) and group 2 (sham-CPAP) * Group 1: This group will perform a 6MWT with CPAP * Group 2: This group will perform a 6MWT with a sham-CPAP

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 3, 2020
• Study Start: March 1, 2023
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)