Using CPAP to improve walking distance in patients with airway collapse
Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)
This study is testing if using a CPAP machine can help people with airway collapse walk farther in six minutes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04217603 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a continuous positive airway pressure (CPAP) device on exercise capacity in adult patients diagnosed with excessive central airway collapse (ECAC). It is a randomized, double-blinded, placebo-controlled trial that aims to determine if CPAP can improve the distance patients can walk in six minutes, as measured by the 6-minute walk test (6MWT). Participants will undergo baseline assessments and then be monitored for changes in their walking distance and symptoms over a three-month period. The study will include 32 patients who have not previously used CPAP devices and will be evaluated through standard pulmonary function tests and bronchoscopy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a confirmed diagnosis of ECAC who have not previously used CPAP devices.
Not a fit: Patients with poorly-controlled respiratory conditions or significant comorbidities that may hinder their ability to improve exercise capacity will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option to improve exercise capacity and quality of life for patients with ECAC.
How similar studies have performed: While CPAP is commonly used for other conditions, this specific application for ECAC is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.