NCT05770518

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Paradoxical Vocal Fold Motion
• Vocal Cord Dysfunction

Interventions

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

Timeline

• Start date: 2023-03-07
• Primary completion: 2024-06-30
• Completion: 2024-07-30
• First posted: 2023-03-15
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States