Recruiting
Phase 3

Translaryngeal Vibration

Sponsor:

Texas Christian University

Code:

NCT07145086

Conditions

Dysphonia

Muscle Tension Dysphonia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Voice therapy with vibration

Study Details

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

Study ID

NCT07145086

Start date

Sep 1, 2024

Status verified date

Aug, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Unable to receive vibration to neck area

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Five Week Therapy

Participants receive five weeks of voice therapy with vibration

active comparator: Eight Week Therapy

Participants receive eight weeks of voice therapy with vibration

placebo comparator: Voice Therapy with Placebo

Participants receive eight weeks of voice therapy with vibration placebo

Interventions

Voice therapy with vibration

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.

Primary outcome measure

  • Voice Handicap Index [ Time Frame: From enrollment to the end of treatment at 5 or 8 weeks" ]

Central Contacts and Locations

Central contacts

Christopher R Watts, Ph.D.

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

Locations

Texas Christian University

Recruiting

Fort Worth, Texas, United States, 76109

Contacts

Christopher R Watts, Ph.D.

817-257-6878c.watts@tcu.edu

Principal Investigator:

Christopher R Watts, Ph.D.

More Information

Sponsor

Texas Christian University

Last update posted

Aug 28, 2025

Last verified

Aug, 2025

Keywords

  • Dysphonia
  • Muscle Tension Dysphonia
  • Voice Therapy
  • Vibration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Christian University on 2025-08-28.