Muscle Tension DysphoniaRTSS-VoiceNCT06152627
Voice Therapy Per the Rehabilitation Treatment Specification System
A study of Muscle Tension Dysphonia, run by Massachusetts General Hospital at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Muscle Tension Dysphonia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Feb 2026to 29 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Amanda Gillespie, PhD, CCC-SLP, 404-778-3381, amanda.i.gillespie@emory.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jarrad Van Stan, PhD, CCC-SLP, 617-643-8410, jvanstan@mgh.harvard.edu
Jeremy Wolfberg, MS, CCC-SLP, jwolfberg@mgb.org
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Susan Thibeault, PhD, CCC-SLP, 608-263-6751, thibeault@surgery.wisc.edu
- Recruiting
New York University
New York, New York, 10017
Aaron Johnson, PhD, CCC-SLP, 646-754-1207, Aaron.Johnson@nyulangone.org
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Julie Barkmeier-Kreamer, PhD, CCC-SLP, 801-585-7143, JulieB.Kraemer@hsc.utah.edu
About this study
Official title: Towards a Unified System to Classify Treatments for Muscle Tension Dysphonia
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.
Read the detailed description
The purpose 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). RTSS-Voice adoption is likely to be associated with improved outcomes because it requires clinicians to think about their therapy in relation to nine evidence-based therapies (i.e., increased evidence-based practice) and more carefully consider the specific changes in targets directly related to specific clinical actions, i.e., improved clinical reasoning. Sixty patents will be enrolled per year (at minimum) from each of the five participating voice centers, i.e., 300 patients in Years 1 and 2 (total patients = 600). For each patient, outcomes will be collected before and after therapy including patient-reported vocal functioning, clinician-reported voice quality, an objective measure associated with overall voice quality (Cepstral Peak Prominence/CPP), and total number of sessions. Each voice center uses different patient-reported and clinician-reported measures. Thus, linear regression models will examine changes in outcomes during Year 1 versus Year 2 for each individual site. The different patient- and clinician-reported measures have been found to be highly correlated. Therefore, individual sites will also be pooled together in a mini meta-analysis. Standardized effect sizes (Cohen's d) will be calculated for each site, representing the effect of RTSS-Voice adoption. Using a fixed effects model, an average effect size across sites will be calculated, weighted by sample size. The average effect size across sites will then represent the overall effect of the implementation on vocal functioning, voice quality, CPP, and number of sessions. Power: The investigators anticipate a minimum of 60 patients per site, (total of 300 patients per year). For site-specific analyses, a sample size of 60 patients for each group (Year 1 versus Year 2) is associated with 80% power to detect the smallest clinically meaningful effect size: d = .5. The effect size d = .5 was chosen because it is the smallest effect that is "visible to the naked eye" associated with rejecting the null hypothesis and supporting the alternative hypothesis in rehabilitation treatment studies and used in multiple voice studies.
- Conditions
- Muscle Tension Dysphonia
- Being tested
- Standard of care voice therapy with novice clinician RTSS-Voice documentation, Standard of care voice therapy with expert clinician RTSS-Voice documentation
- Keywords
- Muscle tension dysphonia, rehabilitation, treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care voice therapy with novice clinician RTSS-Voice documentationBehavioural
Voice therapy is individually tailored to each patient and typically includes behavioral ingredients (e.g., applying pressure to the anterior neck, practice voicing in various ways, feedback on performance, provide information on the importance of therapy concepts) to modify the patient's auditory, somatosensory, vocal, musculoskeletal, respiratory, and mental functions. During this time, the treating clinicians will be trained to use the RTSS-Voice in their clinical documentation.
Standard of care voice therapy with expert clinician RTSS-Voice documentationBehavioural
Voice therapy is individually tailored to each patient and typically includes behavioral ingredients (e.g., applying pressure to the anterior neck, practice voicing in various ways, feedback on performance, provide information on the importance of therapy concepts) to modify the patient's auditory, somatosensory, vocal, musculoskeletal, respiratory, and mental functions. During this time, the treating clinicians will have completed their RTSS-Voice training and using the RTSS-Voice in their clinical documentation.
| Study group | Role | What they receive |
|---|---|---|
| First Year of RTSS-Voice use | Experimental | These 300 patients from five Voice Centers will receive standard of care voice therapy where their treating clinicians will be trained to use the RTSS-Voice in their documentation. Receives: Behavioral: Standard of care voice therapy with novice clinician RTSS-Voice documentation |
| Second Year of RTSS-Voice use | Experimental | These 300 patients from five Voice Centers will receive standard of care voice therapy where their treating clinicians have already been trained to use the RTSS-Voice in their documentation. Receives: Behavioral: Standard of care voice therapy with expert clinician RTSS-Voice documentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice Health Index (VHI)
The VHI consists of 30 Likert questions ranging from 0-4 (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always) that estimate how the patient's vocal function effects his/her daily life. A short-form can be used (the VHI-10) that uses a subset of 10 questions from the 30 total questions. This patient-reported outcome measure will be used to evaluate if the patients perceive that therapy helped them function better in their activities of daily living.
Measured: pre-intervention and immediately after the intervention
Voice-Related Quality of Life (V-RQOL)
The V-RQOL consists of 10 Likert-style questions ranging from 1-5 (1 = none not a problem at all, 2 = a small amount, 3 = a moderate (medium) problem, 4 = a lot, 5 = problem is "as bad as it can be") that estimate how the subject's vocal function effects his/her daily life. This patient-reported outcome measure will be used to evaluate if the patients perceive that therapy helped them function better in their activities of daily living.
Measured: pre-intervention and immediately after the intervention
Consensus Auditory Perceptual Evaluation of Voice (CAPE-V)
The CAPE-V consists of 4 perceptually judged 100-mm visual analog scales (Overall dysphonia, Breathiness, Strain, Roughness). The patient's treating voice specialized speech-language pathologist will judge the audio samples. These judgements provide gold-standard, perceptual ratings of voice quality to evaluate if voice therapy is associated with improved voice quality.
Measured: pre-intervention and immediately after the intervention
Grade Roughness Breathiness Asthenia Strain (GRBAS) Scale
The GRBAS consists of 5 perceptually-judged scales (Grade, Roughness, Breathiness, Asthenia, Strain) on a 0-3 Likert scale (0 = normal, 1 = mild severity, 2 = moderate severity, 3 = severe). The patient's treating voice specialized speech language pathologist will judge the audio samples. These judgements provide gold-standard, perceptual ratings of voice quality to evaluate if voice therapy is associated with improved voice quality.
Measured: pre-intervention and immediately after the intervention
Cepstral Peak Prominence (CPP)
To calculate CPP, all voiced 50 millisecond (ms) frames will undergo two discrete Fourier transforms computed in succession with a logarithmic transformation between them. A regression line is then computed over quefrencies greater than 2 ms (corresponding to a quefrency range minimally affected by subglottal resonances). Finally, the CPP for each frame is defined as the difference, in decibels (dB), between the magnitude of the highest peak and the baseline regression level in the power cepstrum. The peak search is limited to quefrencies between 2.5 ms and 12 ms, corresponding to frequencies of 417 Hertz (Hz) and 83 Hz, respectively. The resulting CPP is an estimate of periodicity in the voice signal, which has strongly correlated to overall dysphonia in multiple previous studies. This will be used to quantitatively evaluate if voice therapy was associated with improved overall voice quality.
Measured: pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start3 Feb 2026
- Primary completion29 Jun 2027 (estimated)
- Study completion29 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Tension DysphoniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, New York University, University of Utah, University of Wisconsin, Madison
- Responsible party
- Principal investigator, Jarrad Van Stan, Massachusetts General Hospital
- Investigators
- Jarrad Van Stan, PhD, CCC-SLP, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152627
- Sponsor's protocol ID
- 2023P003127
- Other IDs
- R01DC020247
- Acronym
- RTSS-Voice
- Status last verified
- May 2026
- First submitted
- 19 Nov 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We expect to share de-identified data on the 600 patients before and after therapy. Specifically, changes in patient-reported outcomes, clinician-reported outcomes, an objective measure of periodicity, and number of therapy sessions.