An interventional study of Biofeedback and Laryngeal control therapy (LCT) in Paradoxical Vocal Fold Motion and Vocal Cord Dysfunction, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
Paradoxical vocal fold motion (PVFM) is characterized by episodic shortness of breath that can range in severity and acuity. Symptoms may greatly impact daily life. Some patients experience severe respiratory distress, which can lead to emergency department visits and occasionally intubation. The standard treatment is typically behavioral therapy performed by speech and language pathologists. However, new evidence suggests that video biofeedback may be an effective alternative treatment. Video biofeedback allows patients to directly visualize their breathing while performing specific breathing exercises. This is a desirable treatment because it can be performed at the time of diagnosis and requires minimal additional time or resources. The investigators' goal is to conduct a pilot randomized controlled trial (RCT) to compare the relative effectiveness of video biofeedback and behavioral therapy in the treatment of PVFM. The primary endpoint will be the change in Dyspnea Index score before treatment and one month after treatment. Patients will complete surveys to collate data about patient expectations of behavioral therapy, their reasons for pursuing additional treatment if applicable, and the perceived benefits of the specific intervention. The investigators hypothesize that no clinically meaningful difference will be detected between behavioral therapy and video biofeedback for the treatment of PVFM. This pilot RCT will provide critical data for designing a fully powered trial comparing these two interventions, and will advance the investigators' goal of providing clinicians with important evidence for guiding treatment.
18 studies on the registry are indexed under Vocal Cord Dysfunction; 4 are open to participants now.
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Exclusion Criteria:
In office video biofeedback performed at the time of the diagnosis.
Behavioral: Biofeedback
A specific type of behavioral therapy performed by speech and language pathologists
Behavioral: Laryngeal control therapy (LCT)
Biofeedback is a strategy used in the treatment of PVFM, which involves allowing patients to directly visualize their breathing patterns during laryngoscopy.
Also known as: Video biofeedback
This treatment typically involves 2 guided therapy sessions that include patient education, relaxation techniques, and training in specific breathing techniques.
Also known as: respiratory retraining
Dyspnea Index (DI)
This is a 10-item questionnaire with scores that range from 0-40, with 40 representing the greatest possible severity of symptoms. The DI is a clinical assessment tool that was designed and validated specifically for patients with upper airway obstruction, including patients with PVFM. The primary outcome measure will be the difference between the two groups in the change in Dyspnea Index (DI).
Time frame: pre and 1 month post treatment
Dyspnea Index (DI)
This is a 10-item questionnaire with scores that range from 0-40, with 40 representing the greatest possible severity of symptoms. The DI is a clinical assessment tool that was designed and validated specifically for patients with upper airway obstruction, including patients with PVFM. The primary outcome measure will be the difference between the two groups in the change in Dyspnea Index (DI).
Time frame: pre and 3 months post treatment
Responder rates
Responder rate is the proportion of subjects at 1 month post-treatment whose Dyspnea Index scores have decreased by at least the minimal clinically important difference.
Time frame: 1 month and 3 months post treatment
The Clinical Global Impressions - Improvement (CGI-I)
This is a widely used research rating tool which will be used to assess the response to treatment using a 7-point Likert scale. A score of 1 represents maximal improvement of symptoms, and a score of 7 represents maximal worsening of symptoms. Language has been adapted to represent participants' changes in breathing quality.
Time frame: 1 month and 3 months post treatment
Qualitative Survey
The investigators will ask participants questions about their expectations of treatment, reasons for pursuing additional treatment if applicable, and perceived utility of their treatment.
Time frame: 3 months post treatment
Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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