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

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Jan 2, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how a device called Continuous Positive Airway Pressure (CPAP) might help adults with a condition called Excessive Dynamic Airway Collapse (ECAC) improve their ability to exercise and manage their symptoms. The main goal is to see how far participants can walk in six minutes after using the CPAP device compared to a placebo (a device that does not provide any treatment). The trial will also look at how well participants can breathe and any changes in their symptoms before and after the walking test.

To join the study, participants need to be at least 18 years old and have a confirmed diagnosis of ECAC. They should also be scheduled for a bronchoscopy, which is a procedure that allows doctors to look inside the airways. It's important that participants have not used a CPAP device before and are in stable health without other serious breathing issues. The trial will include about 32 participants, and each person will be monitored for up to three months. This is a great opportunity for individuals with ECAC to potentially improve their exercise capacity and overall health while contributing to important research.

Gender

ALL

Eligibility 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.