Vocal Cord Dysfunction Clinical Trial
Official title:
Biofeedback vs Laryngeal Control Therapy in Management of Paradoxical Vocal Fold Motion (BLiMP)
Verified date | April 2024 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 51 |
Est. completion date | July 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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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. — View 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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 3 months post treatment | |
Secondary | 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. | 1 month and 3 months post treatment | |
Secondary | 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. | 1 month and 3 months post treatment | |
Secondary | 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. | 3 months post treatment |
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