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RECRUITING
NCT04217603
NA

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

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

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.

Official title: Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2023-03-01

Completion Date

2026-01-31

Last Updated

2025-03-18

Healthy Volunteers

No

Interventions

DEVICE

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

DEVICE

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.

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States