Paradoxical Vocal Fold Motion, Vocal Cord Dysfunction
Conditions
Keywords
laryngeal control therapy, biofeedback, dyspnea, stridor, dysphonia, cough, laryngoscopy
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.
Interventions
BEHAVIORALBiofeedback
Biofeedback is a strategy used in the treatment of PVFM, which involves allowing patients to directly visualize their breathing patterns during laryngoscopy.
BEHAVIORALLaryngeal control therapy (LCT)
This treatment typically involves 2 guided therapy sessions that include patient education, relaxation techniques, and training in specific breathing techniques.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot randomized controlled trial with active treatment control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea Index (DI) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea Index (DI) | 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). |
| Responder rates | 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. |
| The Clinical Global Impressions - Improvement (CGI-I) | 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. |
| Qualitative Survey | 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. |
Countries
United States
Outcome results
None listed