Translaryngeal Vibration for Hyperfunctional Voice Disorders

NCT07145086 | Recruiting Phase 3

• 1 other identifier: 1R15DC021255-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Contemporary treatments for hyperfunctional voice disorders such as muscle tension dysphonia (MTD) are effective but typically do not restore voice handicap or voice function to normal thresholds. Recent reports of vibration as a voice therapy modality have been published, but many questions remain about the efficacy of this tool. The current project addresses these problems through a blinded and randomized controlled trial to investigate the efficacy of local translaryngeal vibration for MTD and the dose-response relationship of this modality when compared to treatment without vibration.

Conditions

Dysphonia; Muscle Tension Dysphonia

Keywords

Dysphonia; Muscle Tension Dysphonia; Voice Therapy; Vibration

Outcome Measures

Primary Outcomes (1)

• Voice Handicap Index

  The Voice Handicap Index (VHI) is a self-assessment tool used to evaluate how a voice disorder impacts a person's daily life, encompassing functional, physical, and emotional aspects. It helps quantify the perceived handicap caused by a voice problem, aiding in diagnosis, treatment planning, and assessing treatment effectiveness. The VHI consists of 30 questions, divided into three subscales, with scores ranging from 0 to 120, where higher scores indicate a greater perceived handicap

  From enrollment to the end of treatment at 5 or 8 weeks"

Secondary Outcomes (1)

• Consensus Auditory-Perceptual Evaluation of Voice

  From enrollment to the end of treatment at 5 or 8 weeks"

Study Arms (3)

Five Week Therapy

EXPERIMENTAL

Participants receive five weeks of voice therapy with vibration

Behavioral: Voice therapy with vibration

Eight Week Therapy

ACTIVE COMPARATOR

Participants receive eight weeks of voice therapy with vibration

Behavioral: Voice therapy with vibration

Voice Therapy with Placebo

PLACEBO COMPARATOR

Participants receive eight weeks of voice therapy with vibration placebo

Behavioral: Voice therapy with vibration

Interventions

Voice therapy with vibration BEHAVIORAL

Voice therapy with a novel vibration device will be delivered for five or eight weeks depending on group allocation. All participants will receive flow phonation voice therapy.

Eight Week Therapy; Five Week Therapy; Voice Therapy with Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a) diagnosis by an otolaryngologist of hyperfunctional dysphonia (MTD) without benign mid-membranous lesion (i.e., primary MTD or non-phonotraumatic hyperfunction) with and a recommendation for voice therapy, ((b) confirmation of dysphonia by a comprehensive voice evaluation conducted by a speech-language pathologist with experience in the evaluation and treatment of voice disordered populations, (c) to prevent floor effects of our primary outcome variable, participants will be required to exhibit a pre-treatment VHI score of \>20, as this is the upper range for normal cutoff values in studies which have demonstrated high sensitivity and specificity for this tool (Behlau et al., 2016), (d) 18 years of age or older, (e) no history of local vibration therapy as part of a rehabilitation treatment program.

You may not qualify if:

• Unable to receive vibration to neck area

Sponsors & Collaborators

• Texas Christian University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76109, United States

RECRUITING

MeSH Terms

Conditions

Dysphonia

Interventions

Vibration

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Central Study Contacts

Christopher R Watts, Ph.D.

CONTACT

817-266-7891; c.watts@tcu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)