Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC (NCT04217603) | Clinical Trial Compass
RecruitingNot Applicable
Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC
United States32 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.