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

The Washington University

Status: Active, not recruiting

Conditions: Paradoxical Vocal Fold Motion; Vocal Cord Dysfunction

Treatments: Behavioral: Laryngeal control therapy (LCT); Behavioral: Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05770518

202210154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Biofeedback

Experimental group

Description:

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

Treatment:

Behavioral: Biofeedback

Laryngeal control therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Laryngeal control therapy (LCT)