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New treatment option for Tracheobronchomalacia
Official title Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC
ClinicalTrials.gov ID: NCT04217603
What this study is testing
- What it's testing
- 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.
- Time commitment: about 3 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.