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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05770518

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Paradoxical Vocal Fold Motion Vocal Cord Dysfunction	Behavioral: Biofeedback Behavioral: Laryngeal control therapy (LCT)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Pilot randomized controlled trial with active treatment control groupPilot randomized controlled trial with active treatment control group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biofeedback In office video biofeedback performed at the time of the diagnosis.	Behavioral: Biofeedback Biofeedback is a strategy used in the treatment of PVFM, which involves allowing patients to directly visualize their breathing patterns during laryngoscopy. Other Names: Video biofeedback
Active Comparator: Laryngeal control therapy A specific type of behavioral therapy performed by speech and language pathologists	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. Other Names: respiratory retraining

Arm

Intervention/Treatment

Experimental: Biofeedback

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

Behavioral: Biofeedback

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

Other Names:

Video biofeedback

Active Comparator: Laryngeal control therapy

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

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.

Other Names:

respiratory retraining

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 question: "Do you have intermittent shortness of breath that is worse when inhaling?"

Exclusion Criteria:

Inability to speak or understand English
Previous diagnosis 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