Actively Recruiting

Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
ID07145086

Translaryngeal Vibration for Hyperfunctional Voice Disorders

Led by Texas Christian University · Updated on 2025-08-28

30

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

T

Texas Christian University

Lead Sponsor

N

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of local translaryngeal vibration therapy combined with flow phonation voice therapy to treat muscle tension dysphonia (MTD), a common hyperfunctional voice disorder. This trial aims to determine the effectiveness of vibration therapy as an added treatment and to understand the relationship between treatment dose and clinical outcomes. The study addresses the ongoing challenge that current voice therapies often do not fully restore normal voice function or reduce voice handicap to typical levels. Participants will be randomly assigned to one of three groups: five weeks of voice therapy with vibration, eight weeks of voice therapy with vibration, or eight weeks of voice therapy with a placebo vibration device. All groups receive flow phonation voice therapy, and the vibration therapy is delivered through a novel device applied locally to the perilaryngeal area. The study uses a single-blind design to compare the effects of different vibration durations and the placebo. During the study, participants will undergo voice therapy sessions over either five or eight weeks, depending on their assigned group. Researchers will assess changes in voice handicap using the Voice Handicap Index from enrollment to the end of treatment. Secondary assessments include auditory-perceptual evaluation of voice quality. The study includes monitoring throughout treatment to evaluate clinical response and safety. Participation involves regular voice evaluations and therapy visits over the treatment period.

CONDITIONS

Brief Title

Translaryngeal Vibration for Hyperfunctional Voice Disorders

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of hyperfunctional dysphonia (MTD) by an otolaryngologist without benign mid-membranous lesion
  • Confirmation of dysphonia by a specialized speech-language pathologist
  • Pre-treatment Voice Handicap Index (VHI) score greater than 20
  • 18 years of age or older
  • No history of local vibration therapy as part of rehabilitation treatment
Not Eligible

You will not qualify if you...

  • Unable to receive vibration therapy to the neck area

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 or 8 weeks depending on group allocation

Participants receive flow phonation voice therapy combined with either translaryngeal vibration or a vibration placebo depending on group assignment.

Weekly visits for up to 8 weeks

Trial Site Locations

Total: 1 location

1

Texas Christian University

Fort Worth, Texas, United States, 76109

Actively Recruiting

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Research Team

C

Christopher R Watts, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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