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

Primary Purpose

Paradoxical Vocal Fold Motion, Vocal Cord Dysfunction

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofeedback
Laryngeal control therapy (LCT)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paradoxical Vocal Fold Motion focused on measuring laryngeal control therapy, biofeedback, dyspnea, stridor, dysphonia, cough, laryngoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biofeedback

Laryngeal control therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
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.

Full Information

First Posted
March 2, 2023
Last Updated
June 19, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05770518
Brief Title
Biofeedback vs Laryngeal Control Therapy in Management of Paradoxical Vocal Fold Motion
Official Title
Biofeedback vs Laryngeal Control Therapy in Management of Paradoxical Vocal Fold Motion (BLiMP)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paradoxical Vocal Fold Motion, Vocal Cord Dysfunction
Keywords
laryngeal control therapy, biofeedback, dyspnea, stridor, dysphonia, cough, laryngoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot randomized controlled trial with active treatment control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
In office video biofeedback performed at the time of the diagnosis.
Arm Title
Laryngeal control therapy
Arm Type
Active Comparator
Arm Description
A specific type of behavioral therapy performed by speech and language pathologists
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Other Intervention Name(s)
Video biofeedback
Intervention Description
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
Intervention Name(s)
Laryngeal control therapy (LCT)
Other Intervention Name(s)
respiratory retraining
Intervention Description
This treatment typically involves 2 guided therapy sessions that include patient education, relaxation techniques, and training in specific breathing techniques.
Primary Outcome Measure Information:
Title
Dyspnea Index (DI)
Description
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
Secondary Outcome Measure Information:
Title
Dyspnea Index (DI)
Description
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
Title
Responder rates
Description
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
Title
The Clinical Global Impressions - Improvement (CGI-I)
Description
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
Title
Qualitative Survey
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Huston, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30956693
Citation
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.
Results Reference
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PubMed Identifier
27861929
Citation
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.
Results Reference
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PubMed Identifier
25152871
Citation
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.
Results Reference
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PubMed Identifier
34699093
Citation
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.
Results Reference
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PubMed Identifier
29631737
Citation
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.
Results Reference
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PubMed Identifier
25836980
Citation
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.
Results Reference
background
PubMed Identifier
25311596
Citation
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.
Results Reference
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PubMed Identifier
33602342
Citation
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.
Results Reference
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PubMed Identifier
25104182
Citation
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.
Results Reference
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PubMed Identifier
20526405
Citation
Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
Results Reference
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Biofeedback vs Laryngeal Control Therapy in Management of Paradoxical Vocal Fold Motion

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