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

NCT05770518 | Completed DMC

• 1 other identifier: 202210154
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Paradoxical Vocal Fold Motion; Vocal Cord Dysfunction

Keywords

laryngeal control therapy; biofeedback; dyspnea; stridor; dysphonia; cough; laryngoscopy

Outcome Measures

Primary Outcomes (1)

• 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).

  pre and 1 month post treatment

Secondary Outcomes (4)

• Dyspnea Index (DI)

  pre and 3 months post treatment

• Responder rates

  1 month and 3 months post treatment

• The Clinical Global Impressions - Improvement (CGI-I)

  1 month and 3 months post treatment

• Qualitative Survey

  3 months post treatment

Study Arms (2)

Biofeedback

EXPERIMENTAL

In office video biofeedback performed at the time of the diagnosis.

Behavioral: Biofeedback

Laryngeal control therapy

ACTIVE COMPARATOR

A specific type of behavioral therapy performed by speech and language pathologists

Behavioral: Laryngeal control therapy (LCT)

Interventions

Biofeedback BEHAVIORAL

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

Biofeedback

Laryngeal control therapy (LCT) BEHAVIORAL

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

Laryngeal control therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)?"

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (11)

• George S, Suresh S. Vocal Cord Dysfunction: Analysis of 27 Cases and Updated Review of Pathophysiology & Management. Int Arch Otorhinolaryngol. 2019 Apr;23(2):125-130. doi: 10.1055/s-0038-1661358. Epub 2018 Oct 24.

  PMID: 30956693 BACKGROUND

• Kramer S, deSilva B, Forrest LA, Matrka L. Does treatment of paradoxical vocal fold movement disorder decrease asthma medication use? Laryngoscope. 2017 Jul;127(7):1531-1537. doi: 10.1002/lary.26416. Epub 2016 Nov 15.

  PMID: 27861929 BACKGROUND

• Guglani L, Atkinson S, Hosanagar A, Guglani L. A systematic review of psychological interventions for adult and pediatric patients with vocal cord dysfunction. Front Pediatr. 2014 Aug 8;2:82. doi: 10.3389/fped.2014.00082. eCollection 2014.

  PMID: 25152871 BACKGROUND

• Mahoney J, Hew M, Vertigan A, Oates J. Treatment effectiveness for Vocal Cord Dysfunction in adults and adolescents: A systematic review. Clin Exp Allergy. 2022 Mar;52(3):387-404. doi: 10.1111/cea.14036. Epub 2021 Nov 4.

  PMID: 34699093 BACKGROUND

• Shaffer M, Litts JK, Nauman E, Haines J. Speech-Language Pathology as a Primary Treatment for Exercise-Induced Laryngeal Obstruction. Immunol Allergy Clin North Am. 2018 May;38(2):293-302. doi: 10.1016/j.iac.2018.01.003. Epub 2018 Mar 2.

  PMID: 29631737 BACKGROUND

• Patel RR, Venediktov R, Schooling T, Wang B. Evidence-Based Systematic Review: Effects of Speech-Language Pathology Treatment for Individuals With Paradoxical Vocal Fold Motion. Am J Speech Lang Pathol. 2015 Aug;24(3):566-84. doi: 10.1044/2015_AJSLP-14-0120.

  PMID: 25836980 BACKGROUND

• Gartner-Schmidt JL, Shembel AC, Zullo TG, Rosen CA. Development and validation of the Dyspnea Index (DI): a severity index for upper airway-related dyspnea. J Voice. 2014 Nov;28(6):775-82. doi: 10.1016/j.jvoice.2013.12.017. Epub 2014 Oct 12.

  PMID: 25311596 BACKGROUND

• LeBlanc RA, Aalto D, Jeffery CC. Visual biofeedback for paradoxical vocal fold motion (PVFM). J Otolaryngol Head Neck Surg. 2021 Feb 18;50(1):13. doi: 10.1186/s40463-021-00495-0.

  PMID: 33602342 BACKGROUND

• De Guzman V, Ballif CL, Maurer R, Hartnick CJ, Raol N. Validation of the dyspnea index in adolescents with exercise-induced paradoxical vocal fold motion. JAMA Otolaryngol Head Neck Surg. 2014 Sep;140(9):823-8. doi: 10.1001/jamaoto.2014.1405.

  PMID: 25104182 BACKGROUND

• Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.

  PMID: 20526405 BACKGROUND

• Strober WA, Rohlfing ML, Cutchin GM, Kallogjeri D, Piccirillo JF, Huston MN. Biofeedback vs Respiratory Retraining for Inducible Laryngeal Obstruction: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Feb 1;152(2):182-190. doi: 10.1001/jamaoto.2025.4542.

  PMID: 41379457 DERIVED

MeSH Terms

Conditions

Vocal Cord Dysfunction; Dyspnea; Respiratory Sounds; Dysphonia; Cough

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Margaret Huston, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomized controlled trial with active treatment control group

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 15, 2023
• Study Start: March 7, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)