Recruiting

RTSS-Voice

Sponsor:

Massachusetts General Hospital

Code:

NCT06152627

Conditions

Muscle Tension Dysphonia

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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

Study ID

NCT06152627

Start date

Feb 3, 2026

Status verified date

May, 2026

Completion date

Jun 29, 2027

Anticipated

Primary completion date

Jun 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

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

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 documentation

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.

Primary outcome measure

  • Voice Health Index (VHI) [ Time Frame: pre-intervention and immediately after the intervention ]
  • Voice-Related Quality of Life (V-RQOL) [ Time Frame: pre-intervention and immediately after the intervention ]
  • Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) [ Time Frame: pre-intervention and immediately after the intervention ]
  • Grade Roughness Breathiness Asthenia Strain (GRBAS) Scale [ Time Frame: pre-intervention and immediately after the intervention ]
  • Cepstral Peak Prominence (CPP) [ Time Frame: pre-intervention and immediately after the intervention ]

Central Contacts and Locations

Central contacts

Jarrad Van Stan, PhD, CCC-SLP

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

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Amanda Gillespie, PhD, CCC-SLP

404-778-3381amanda.i.gillespie@emory.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jarrad Van Stan, PhD, CCC-SLP

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

Jeremy Wolfberg, MS, CCC-SLP

jwolfberg@mgb.org

New York University

Recruiting

New York, New York, United States, 10017

Contacts

Aaron Johnson, PhD, CCC-SLP

646-754-1207Aaron.Johnson@nyulangone.org

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Julie Barkmeier-Kreamer, PhD, CCC-SLP

801-585-7143JulieB.Kraemer@hsc.utah.edu

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Susan Thibeault, PhD, CCC-SLP

608-263-6751thibeault@surgery.wisc.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Muscle tension dysphonia
  • rehabilitation
  • treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-26.