Voice therapy guided by the RTSS-Voice standardized coding system
Towards a Unified System to Classify Treatments for Muscle Tension Dysphonia
This project will test whether using a standardized coding system (RTSS-Voice) to document voice therapy sessions helps people with muscle tension dysphonia improve their voice.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Atlanta, Georgia and 4 other locations) |
| Trial ID | NCT06152627 on ClinicalTrials.gov |
What this trial studies
Clinicians across five voice centers will use RTSS-Voice to document standard-of-care voice therapy and outcomes for patients with primary muscle tension dysphonia. The study will compare outcomes for patients treated during a clinician's first year using RTSS-Voice versus their second year using RTSS-Voice. About 300 patients per year (600 total) will have pre- and post-therapy measures collected, including patient-reported vocal function, clinician-rated voice quality, Cepstral Peak Prominence (CPP), and number of sessions. Each site will analyze year-to-year changes with linear regression and results will be pooled in a mini meta-analysis to estimate overall effects.
Who should consider this trial
Good fit: Ideal candidates are English-speaking patients diagnosed with primary muscle tension dysphonia (any subtype) who do not have structural, neurological, or respiratory disorders and who receive care at a participating voice center.
Not a fit: Patients with structural lesions, neurogenic voice disorders, significant respiratory conditions, non-English speakers, or those treated outside the participating centers are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could lead to clearer, more targeted therapy plans and better voice outcomes for people with muscle tension dysphonia.
How similar studies have performed: RTSS frameworks have been applied in rehabilitation to promote specific, evidence-based treatment targeting, but using RTSS-Voice for clinical voice therapy outcomes is relatively novel with limited prior outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of primary Muscle Tension Dysphonia (pMTD) * Patients with pMTD will be included regardless of subtype (e.g., functional aphonia, vocal fry, ventricular dysphonia) and they can have secondary diagnoses of reflux. Exclusion Criteria: * Patients diagnosed with pMTD will be excluded if they have secondary diagnoses related to structural, neurological, or respiratory disorders such as laryngitis, obvious vocal fold nodules, polyps, cyst, granuloma, sulci, paradoxical vocal fold motion, chronic cough, confirmed or possible upper airway paralysis/paresis, dysphagia, polypoid corditis, keratosis, presbylarynx, leukoplakia, or history of radiation to the head/neck. Patients with pMTD will be included regardless of subtype (e.g., functional aphonia, vocal fry, ventricular dysphonia) and they can have secondary diagnoses of reflux. * Non-English speakers. The RTSS-Voice's standard and operationalized categories are in English.
Where this trial is running
Atlanta, Georgia and 4 other locations
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- New York University — New York, New York, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Jarrad Van Stan, PhD, CCC-SLP — Massachusetts General Hospital
- Study coordinator: Jarrad Van Stan, PhD, CCC-SLP
- Email: jvanstan@mgh.harvard.edu
- Phone: 617-643-8410
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.