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

June 19, 2023 updated by: Margaret (Molly) Huston, Washington University School of Medicine

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • Initiation of symptoms within 3 months of a COVID infection
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofeedback
In office video biofeedback performed at the time of the diagnosis.
Behavioral: Biofeedback
Biofeedback is a strategy used in the treatment of PVFM, which involves allowing patients to directly visualize their breathing patterns during laryngoscopy.
Other Names:
  • Video biofeedback
Active Comparator: Laryngeal control therapy
A specific type of behavioral therapy performed by speech and language pathologists
Behavioral: Laryngeal control therapy (LCT)
This treatment typically involves 2 guided therapy sessions that include patient education, relaxation techniques, and training in specific breathing techniques.
Other Names:
  • respiratory retraining

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea Index (DI)
Time Frame: pre and 1 month post treatment

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).
pre and 1 month post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea Index (DI)
Time Frame: pre and 3 months post treatment

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).
pre and 3 months post treatment
Responder rates
Time Frame: 1 month and 3 months post treatment
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.
1 month and 3 months post treatment
The Clinical Global Impressions - Improvement (CGI-I)
Time Frame: 1 month and 3 months post treatment
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.
1 month and 3 months post treatment
Qualitative Survey
Time Frame: 3 months post treatment
The investigators will ask participants questions about their expectations of treatment, reasons for pursuing additional treatment if applicable, and perceived utility of their treatment.
3 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Margaret Huston, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2023

Primary Completion (Estimated)

October 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202210154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vocal Cord Dysfunction

Clinical Trials on Biofeedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe