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Device
CPAP for Excessive Dynamic Airway Collapse
Boston, MA
N/A
Recruiting
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Summary
This trial will test whether a CPAP machine can help improve the exercise capacity and symptoms of people with ECAC. 32 people will be monitored for 3 months.
See full description
Who is the study for?
Adults over 18 with ECAC confirmed by bronchoscopy or CT scan, who can walk more than 140m in six minutes and have never used CPAP devices. Excluded are those with conditions affecting the trial's assessments, poorly-controlled respiratory issues, recent infections, certain heart rhythm problems, sensitivity to sedation drugs for bronchoscopy, or severe physical limitations not related to breathing.
What is being tested?
The study tests if a CPAP device improves exercise capacity in ECAC patients compared to a sham (fake) device. Participants will be randomly assigned to one of the two groups without knowing which one they're in and monitored during a standard 6-minute walk test among other measures.See study design
What are the potential side effects?
While CPAP is generally safe and FDA-approved for other conditions, potential side effects may include discomfort at the mask site, dry nose or throat, headaches, bloating from swallowed air and possible ear discomfort due to pressure changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in meters walked in 6MWTs
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1Experimental Treatment1 Intervention
This group will perform a 6MWT with CPAP
Group II: Group 2Placebo Group1 Intervention
This group will perform a 6MWT with a sham-CPAP
Find a Location
Closest Location:Beth Israel Deaconess Medical Center· Boston, MA· 641 miles
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
869 Previous Clinical Trials
12,930,890 Total Patients Enrolled
4 Trials studying Tracheobronchomalacia
361 Patients Enrolled for Tracheobronchomalacia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a health problem that makes it hard to finish the required check-ups.You cannot walk more than 140 meters (150 yards) in 6 minutes.You have a heart rhythm problem that could be dangerous during physical activity or training.You cannot tolerate a bronchoscopy with light sedation or full anesthesia.You have respiratory conditions like asthma, COPD, sleep apnea, acid reflux, or relapsing polychondritis that are not well managed.You have not had a respiratory tract infection in the last 3 weeks.Your resting heart rate is very slow (less than 50 beats per minute) or you have certain types of irregular heartbeats.You have been diagnosed with ECAC through a bronchoscopy or CT scan.You have other health conditions that could make it hard for you to improve your ability to exercise, or your difficulty walking is not mainly because of breathing problems.You are over 18 years old.You are scheduled to have a bronchoscopy as part of your regular medical care.It seems like the criterion is incomplete. However, it appears to be related to the 6-minute walk test (6 MWT), which is a test to measure the distance a person can walk quickly in 6 minutes on a flat, hard surface. If you have any additional information about this criterion, please feel free to provide it, and I can help you summarize it.You have never used CPAP devices before.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.