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Biofeedback vs Laryngeal Control Therapy for Vocal Cord Dysfunction
N/A
Waitlist Available
Led By Margaret Huston, MD
Research Sponsored by Washington University School of Medicine
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 1 month and 3 months post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two treatments for people with Paradoxical Vocal Fold Motion (PVFM), a condition causing shortness of breath. One treatment uses video feedback to help patients see and improve their breathing, while the other involves working with a therapist to control vocal cords. The goal is to see which method is more effective in reducing symptoms.
Who is the study for?
This trial is for adults over 18 with Paradoxical Vocal Fold Motion, experiencing significant breathing difficulty during inhalation. They must have a specific score indicating abnormal breathlessness and be referred to the Washington University School of Medicine Voice and Airway Center. Those who've had laryngeal surgery, other vocal cord issues, can't speak English, or had recent COVID-related symptoms are excluded.
What is being tested?
The study compares biofeedback therapy against Laryngeal Control Therapy (LCT) in treating PVFM. Participants will receive one of these treatments randomly and complete surveys about their symptoms before and after treatment to assess changes.
What are the potential side effects?
Since this trial involves non-invasive therapies focusing on breathing techniques and feedback mechanisms rather than drugs or surgeries, side effects may include discomfort from unfamiliar exercises or frustration if improvements aren't immediate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month and 3 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month and 3 months post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dyspnea Index (DI)
Secondary study objectives
Qualitative Survey
Responder rates
The Clinical Global Impressions - Improvement (CGI-I)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BiofeedbackExperimental Treatment1 Intervention
In office video biofeedback performed at the time of the diagnosis.
Group II: Laryngeal control therapyActive Control1 Intervention
A specific type of behavioral therapy performed by speech and language pathologists
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biofeedback
2016
Completed Phase 4
~1280
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,833 Total Patients Enrolled
Margaret Huston, MDPrincipal InvestigatorWashington University School of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had surgery on your voice box (larynx) in the past.If you have a score of 11 or higher on the breathing difficulty test before treatment, you may not be able to join the study.You have another condition in your larynx that is blocking the airflow, such as a growth or a narrowing.You started having symptoms within 3 months of getting COVID.People who are 18 years old or older.You have received treatment for PVFM in the past.You have trouble breathing sometimes, and it gets worse when you breathe in.
Research Study Groups:
This trial has the following groups:- Group 1: Biofeedback
- Group 2: Laryngeal control therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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