RECRUITING

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

Conditions

Tracheobronchomalacia Excessive Dynamic Airway Collapse Continuous Positive Airway Pressure Excessive Central Airway Collapse

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)

Quick Facts

Study Start:2023-03-01

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04217603

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2023-03-01

Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

Continuous Positive Airway Pressure
Tracheobronchomalacia
Excessive Dynamic Airway Collapse
Excessive Central Airway Collapse

Additional Relevant MeSH Terms

Tracheobronchomalacia
Excessive Dynamic Airway Collapse