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

Conditions

• Excessive Dynamic Airway Collapse
• Tracheobronchomalacia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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
• 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.

Study Details

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.

Key Dates

Start date

Mar 1, 2023

Status verified

Apr 2026

Primary completion

Sep 29, 2026

Completion

Sep 29, 2026

Study Design

Enrollment

32 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

Primary Outcome Measure

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

Locations (1)

Find similar trials in Boston, MA

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