CompletedNot Applicable

Biofeedback vs Laryngeal Control Therapy in Management of Paradoxical Vocal Fold Motion

United States51 participantsStarted 2023-03-07

Plain-language summary

Paradoxical Vocal Fold Motion (PVFM) is a condition where vocal cords adduct (move toward another) instead of abduct (move away from one another) during inspiration, thus causing shortness of breath. The goal of this pilot randomized controlled trial is to compare the efficacy of biofeedback as compared to laryngeal control therapy (LCT) in the treatment of PVFM. Participants will take surveys about their symptoms and their expectations of treatment prior to initiating treatment and after completion of their assigned treatment. Researchers will compare the biofeedback group to the LCT group to see if participants have differences in changes of their symptoms.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women aged 18 or older * Referral to the Washington University School of Medicine Voice and Airway Center for concerns for PVFM * Pre-treatment Dyspnea Index score of 11 or higher (representing the threshold for having an abnormal score) * Answer yes to the following questions: "Do you sometimes have difficulty breathing?" and "When you have difficulty breathing, is it worse when inhaling (breathing in)?" Exclusion Criteria: * Inability to speak or understand English * Previous treatment of PVFM * History of laryngeal surgery * Evidence of alternative laryngeal pathology (e.g. subglottic stenosis, benign or malignant obstructive mass) on flexible laryngoscopy as performed as part of routine clinical care

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dyspnea Index (DI)

Timeframe: pre and 1 month post treatment

Trial details

NCT IDNCT05770518

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Paradoxical Vocal Fold Motion trials