Neck vibration plus voice therapy for muscle tension dysphonia
Translaryngeal Vibration for Hyperfunctional Voice Disorders
This trial will test whether adding gentle translaryngeal (neck) vibration to standard voice therapy helps adults with muscle tension dysphonia improve their voice.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Texas Christian University Academic / other |
| Locations | 1 site (Fort Worth, Texas) |
| Trial ID | NCT07145086 on ClinicalTrials.gov |
What this trial studies
This is a randomized, blinded, controlled Phase 3 trial comparing standard flow-phonation voice therapy delivered with local translaryngeal vibration versus the same therapy without vibration and exploring dose-response effects. Adults with primary muscle tension dysphonia and elevated voice handicap (VHI > 20) are enrolled and randomized to receive therapy with differing vibration doses or no vibration. Outcomes include patient-reported voice handicap and physiological voice measures collected before and after treatment to determine clinical benefit. The design uses rigorous blinding and standardized therapy procedures to isolate the effect of the vibration modality.
Who should consider this trial
Good fit: Adults (18+) diagnosed with primary muscle tension dysphonia without benign mid-membranous lesions, confirmed by an experienced speech-language pathologist, with a pre-treatment VHI score over 20 and no prior local vibration therapy are ideal candidates.
Not a fit: Patients with structural vocal fold lesions, those unable to receive neck vibration, people with VHI scores at or below normal thresholds, or those who previously received local vibration therapy are unlikely to benefit from this specific intervention.
Why it matters
Potential benefit: If successful, adding translaryngeal vibration could improve voice function and reduce voice handicap beyond standard therapy for people with muscle tension dysphonia.
How similar studies have performed: Early pilot and small studies of local translaryngeal vibration have reported physiological and clinical improvements, but high-quality randomized evidence has been limited until now.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Fort Worth, Texas
- Texas Christian University — Fort Worth, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Christopher R Watts, Ph.D.
- Email: c.watts@tcu.edu
- Phone: 817-266-7891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.