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Device

CPAP for Excessive Dynamic Airway Collapse

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
Patient with a diagnosis of ECAC either via bronchoscopy or CT Scan
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study 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.

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.Check my eligibility
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with ECAC through a bronchoscopy or CT scan.
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You are over 18 years old.
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You are scheduled to have a bronchoscopy as part of your regular medical care.
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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.
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You have never used CPAP devices before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in meters walked in 6MWTs
Secondary outcome measures
Modified Borg scale scores for dyspnea
Modified Borg scale scores for exertion
Subjective assestment of cough during 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

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
835 Previous Clinical Trials
13,006,498 Total Patients Enrolled
4 Trials studying Tracheobronchomalacia
361 Patients Enrolled for Tracheobronchomalacia

Media Library

Continuous positive airway pressure (CPAP) device (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04217603 — N/A
Tracheobronchomalacia Research Study Groups: Group 1, Group 2
Tracheobronchomalacia Clinical Trial 2023: Continuous positive airway pressure (CPAP) device Highlights & Side Effects. Trial Name: NCT04217603 — N/A
Continuous positive airway pressure (CPAP) device (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04217603 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there presently an opportunity to participate in this experiment?

"According to clinicaltrials.gov, this study is no longer actively recruiting patients and the last edits were made on November 17th 2022. Nonetheless, there are presently 138 other medical trials currently searching for participants."

Answered by AI
~16 spots leftby Mar 2025