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

NCT ID: NCT05770518

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-07

Study Completion Date

2024-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Paradoxical Vocal Fold Motion Vocal Cord Dysfunction

Keywords

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laryngeal control therapy biofeedback dyspnea stridor dysphonia cough laryngoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot randomized controlled trial with active treatment control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biofeedback

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

Group Type EXPERIMENTAL

Biofeedback

Intervention Type BEHAVIORAL

Biofeedback is a strategy used in the treatment of PVFM, which involves allowing patients to directly visualize their breathing patterns during laryngoscopy.

Laryngeal control therapy

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

Group Type ACTIVE_COMPARATOR

Laryngeal control therapy (LCT)

Intervention Type BEHAVIORAL

This treatment typically involves 2 guided therapy sessions that include patient education, relaxation techniques, and training in specific breathing techniques.

Interventions

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Biofeedback

Biofeedback is a strategy used in the treatment of PVFM, which involves allowing patients to directly visualize their breathing patterns during laryngoscopy.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Video biofeedback respiratory retraining

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret Huston, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30956693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27861929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25152871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34699093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29631737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25836980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25311596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33602342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25104182 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 20526405 (View on PubMed)

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. 2025 Dec 11. doi: 10.1001/jamaoto.2025.4542. Online ahead of print.

Reference Type DERIVED
PMID: 41379457 (View on PubMed)

Other Identifiers

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202210154

Identifier Type: -

Identifier Source: org_study_id