Voice Therapy Per the Rehabilitation Treatment Specification System

NCT06152627 | Recruiting

• 1 other identifier: 2023P003127
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Muscle Tension Dysphonia

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  pre-intervention and immediately after the intervention

Study Arms (2)

First Year of RTSS-Voice use

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.

Behavioral: Standard of care voice therapy with novice clinician RTSS-Voice documentation

Second Year of RTSS-Voice use

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.

Behavioral: Standard of care voice therapy with expert clinician RTSS-Voice documentation

Interventions

Standard of care voice therapy with expert clinician RTSS-Voice documentation BEHAVIORAL

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.

Second Year of RTSS-Voice use

Standard of care voice therapy with novice clinician RTSS-Voice documentation BEHAVIORAL

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.

First Year of RTSS-Voice use

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All recruited patients will be diagnosed with primary Muscle Tension Dysphonia (pMTD) because: \[1\] clinical impact - pMTD is the most commonly treated voice disorder; \[2\] minimal diagnostic confounds - pMTD is ostensibly behavioral (i.e., no variations in disordered anatomy/physiology) and voice therapy is the only curative option (i.e., minimal presence of other treatments like sur-gery); \[3\] comprehensive coverage of therapy concepts - pMTD is the most heterogeneous voice disorder; \[4\] availability of multiple therapies with similar outcomes - allowing us to use previously developed methods for identifying unique targets/ingredients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Emory University: collaborator
• New York University: collaborator
• University of Utah: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (5)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

New York University

New York, New York, 10017, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

Study Officials

• Jarrad Van Stan, PhD, CCC-SLP

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarrad Van Stan, PhD, CCC-SLP

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery and Speech-Language Pathology

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 30, 2023
• Study Start: February 3, 2026
• Primary Completion (Estimated): June 29, 2027
• Study Completion (Estimated): June 29, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data collection will be finished by August 2027. Since the data is de-identified at time of data collection, we will plan to submit the data as soon as possible to a generalist repository approved by the PI's home institution and meets all National Institutes of Health Generalist Repository requirements: Harvard Dataverse. The National Institute on Deafness and Other Communication Disorders participates in multiple domain specific repositories (aphasia, fluency, multiple brain repositories, mice work, and Downs syndrome). However, there are no domain-specific repositories for voice, voice disorders, or motor control/learning data.
• Access Criteria: The study datasets will be collected with the following informed consent: Health/Medical/Biomedical. To maximize the appropriate sharing of scientific data and protect research participants' privacy and confidentiality, reuse of this dataset should use the following Data Use Limitations under Controlled Access that is made available by a data repository only after approval of the request by the Harvard Dataverse independent review panel process.

Locations

US (5)