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nPEP (non-invasive positive expiratory pressure) mask for Tracheobronchomalacia
N/A
Waitlist Available
Led By Loretta G Que, MD
Research Sponsored by Duke University
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 baseline, two weeks
Awards & highlights
Study Summary
This trial will test if a device that helps you breathe out can reduce coughing, help you breathe better, and improve quality of life for people with TBM who can't have stenting.
Eligible Conditions
- Tracheobronchomalacia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, two weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, two weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cough Severity as Measured by the Cough Visual Analog Scale (VAS)
Change in Quality of Life as Measured by the Cough-Specific Quality-of-Life Questionnaire (CQLQ)
Change in Quality of Life as Measured by the Leicester Cough Questionnaire (LCQ)
Secondary outcome measures
Proximal Airway Reactance at 5 Hz (X5) as Assessed by Impulse Oscillometry
Trial Design
1Treatment groups
Experimental Treatment
Group I: nPEP RecipientsExperimental Treatment1 Intervention
Single-patient, adjustable expiratory resistance device that provides positive pressure (5 to 20 cm H2O) during expiration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nPEP (non-invasive positive expiratory pressure) mask
2021
N/A
~10
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,420,059 Total Patients Enrolled
Loretta G Que, MDPrincipal InvestigatorDuke University
Frequently Asked Questions
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