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NCT04217603 · ClinicalTrials.gov registry record · NA
Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC
A NA study of Tracheobronchomalacia and Excessive Dynamic Airway Collapse, sponsored by Beth Israel Deaconess Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT04217603: Recruiting NA study of Tracheobronchomalacia and Excessive Dynamic Airway Collapse, sponsored by Beth Israel Deaconess Medical Center.
NCT04217603 is a NA study of Tracheobronchomalacia and Excessive Dynamic Airway Collapse that is actively recruiting participants, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04217603, a NA study of Tracheobronchomalacia and Excessive Dynamic Airway Collapse, is actively recruiting participants, sponsored by Beth Israel Deaconess Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Continuous positive airway pressure (CPAP) device
- DEVICE Sham-continuous positive airway pressure (CPAP) device
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2026-01-31 |
| Phase | NA |
What NCT04217603 shows while recruiting
NCT04217603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Tracheobronchomalacia appearing as the primary indexed condition, and to 2 interventions - of which Continuous positive airway pressure (CPAP) device is the first listed.
NCT04217603 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04217603 about?
NCT04217603 is a clinical study titled "Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC". 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 tot...
What is the current status of trial NCT04217603?
This trial is currently recruiting. It is a NA study. The enrollment target is 32 participants. The study started on 2023-03-01. Estimated completion is 2026-01-31.
What conditions does trial NCT04217603 study?
This clinical trial studies the following conditions: Tracheobronchomalacia, Excessive Dynamic Airway Collapse.
What interventions are being tested in trial NCT04217603?
The interventions under investigation include: Continuous positive airway pressure (CPAP) device (DEVICE), Sham-continuous positive airway pressure (CPAP) device (DEVICE).
Who is sponsoring clinical trial NCT04217603?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04217603 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04217603's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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