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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 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

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· 1444 miles

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
869 Previous Clinical Trials
12,930,891 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
~11 spots leftby Mar 2026