RecruitingNot Applicable

Voice Therapy Per the Rehabilitation Treatment Specification System

United States600 participantsStarted 2026-02-03

Plain-language summary

The goal of this study is to evaluate if using evidence-based, standard ingredient and target codes from the Rehabilitation Treatment Specification System - Voice Therapy (RTSS-Voice) in standard of care voice therapy documentation can improve outcomes for patients with muscle tension dysphonia (MTD). The main question it aims to answer is: Since the RTSS-Voice will help clinicians think about their treatment more specifically and in relation to nine evidence-based therapies, will its adoption be associated with improved outcomes? Clinicians across five voice centers will be asked to use the RTSS-Voice to document their voice therapy sessions for patients with MTD. Researchers will compare changes in outcomes between two groups of patients: those treated during the clinician's first year using the RTSS-Voice versus those treated during the clinician's second year using the RTSS-Voice.

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Voice Health Index (VHI)

Timeframe: pre-intervention and immediately after the intervention

Voice-Related Quality of Life (V-RQOL)

Timeframe: pre-intervention and immediately after the intervention

Consensus Auditory Perceptual Evaluation of Voice (CAPE-V)

Timeframe: pre-intervention and immediately after the intervention

Grade Roughness Breathiness Asthenia Strain (GRBAS) Scale

Timeframe: pre-intervention and immediately after the intervention

Cepstral Peak Prominence (CPP)

Timeframe: pre-intervention and immediately after the intervention

Trial details

NCT IDNCT06152627

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-29

Contact for this trial

Jarrad Van Stan, PhD, CCC-SLP

617-643-8410 jvanstan@mgh.harvard.edu

View on ClinicalTrials.gov More Muscle Tension Dysphonia trials

Plain-language summary

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Voice Health Index (VHI)

Timeframe: pre-intervention and immediately after the intervention

Voice-Related Quality of Life (V-RQOL)

Timeframe: pre-intervention and immediately after the intervention

Consensus Auditory Perceptual Evaluation of Voice (CAPE-V)

Timeframe: pre-intervention and immediately after the intervention

Grade Roughness Breathiness Asthenia Strain (GRBAS) Scale

Timeframe: pre-intervention and immediately after the intervention

Cepstral Peak Prominence (CPP)

Timeframe: pre-intervention and immediately after the intervention