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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 32
Treatments
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
Sponsors
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov

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