Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes

NCT07176988 | Recruiting

• 2 other identifiers: STUDY000091211R01DC022026-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This research study aims to evaluate the effect of treatment delivery method on voice outcomes over 12 months in people with a primary complaint of a voice problem, diagnosed with either non-phonotraumatic vocal hyperfunction, also known as primary muscle tension dysphonia (MTD) or phonotraumatic vocal hyperfunction, also known as benign vocal fold lesions (lesions). The secondary objectives are:

• To evaluate acoustic correlates of clear speech and the relationship to vocal acoustic and patient-reported voice outcomes.
• To determine the association between overall dysphonia outcomes and adoption of clear speech.

Conditions

Dysphonia; Primary Muscle Tension Dysphonia (MTD)

Keywords

Conversation Training Therapy; Hierarchical Conversation Training Therapy; primary muscle tension dysphonia; benign vocal fold lesions

Outcome Measures

Primary Outcomes (2)

• Change in Voice Handicap Index-10 (VHI-10) score

  The Voice Handicap Index-10 (VHI-10) is a 10-question survey used to measure how much a voice problem affects a person's daily life. Scores range from 0 to 40, with higher scores indicating a greater perceived voice handicap. Each item is rated from 0 ("never") to 4 ("always") A higher score means greater voice-related disability as perceived by the patient.

  During intervention (4 week period of active treatment: Week 1, Week 2, Week 3, Week 4) immediately post treatment ( week 5), 3month, 6 month and 12-months post treatment

• Change in vowel space

  Change in vowel space refers to alterations in the acoustic range of vowel production-specifically, how far apart vowels are from each other in the formant frequency space (typically plotted as F1 vs F2, the first and second formants). It reflects the clarity, precision, and distinctiveness of vowel articulation during speech. Vowel space will be measured through acoustic analysis of participants' spoken sentences from the Sentence Intelligibility Test (SIT). These sentences include both corner vowels (e.g., heed, had, hod, who'd) and non-corner vowels (e.g., hid, head, hut, hood), allowing for detailed tracking of articulatory patterns

  During intervention (4 week period of active treatment: Week 1, Week 2, Week 3, Week 4) immediately post treatment ( week 5), 3month, 6 month and 12-months post treatment.

Secondary Outcomes (13)

• Auditory- Perceptual severity

  Baseline , 3 month, 6 month, 12 month

• Stroboscopic changes: Glottal Closure

  Baseline, Post intervention (1 week), 3 month, 6 month, 12 month

• Stroboscopic changes: Amplitude

  Baseline, Post intervention (1 week), 3 month, 6 month, 12 month

• Stroboscopic changes: Mucosal Wave

  Baseline, Post intervention (1 week), 3 month, 6 month, 12 month

• Stroboscopic changes: Free edge contour

  Baseline, Post intervention (1 week), 3 month, 6 month, 12 month

Study Arms (2)

Non-Hierarchical Conversation Training Therapy (CTT)

EXPERIMENTAL

Other: Non Hierarchical method

Hierarchical Conversation Training Therapy (CTT-H)

EXPERIMENTAL

Other: Hierarchical method

Interventions

Hierarchical method OTHER

Participants in the hierarchical version of Conversation Training Therapy (CTTH) will receive four weekly sessions of voice therapy. This approach gradually increases the difficulty of speaking tasks-from simple sounds to full conversations-based on the participant's progress. The therapy begins with basic awareness and speech sounds (e.g., consonant-vowel pairs), then progresses through words, phrases, and sentences, culminating in natural conversation. Each level must be completed with at least 80% accuracy before proceeding to the next one. The structure is modeled after traditional voice therapies like resonant voice and aims to help participants succeed early and reduce mental fatigue. Daily homework includes seven short (2.5-minute) practice sessions, aligned with prior research showing this is a realistic and effective amount of practice.

Hierarchical Conversation Training Therapy (CTT-H)

Non Hierarchical method OTHER

The therapy includes four weekly sessions and several key techniques: Clear Speech: Speaking clearly, like leaving an important voicemail. Awareness Training: Paying attention to how the voice sounds and feels in the mouth and face. Negative Practice: Switching between their "bad" voice and "good" therapy voice to recognize and improve differences. Embedded Gestures: Briefly holding certain speech sounds to reduce vocal strain and boost clarity. Prosody and Projection: Working on pitch, rhythm, and speaking louder through better technique. Participants practice these skills throughout the day using a mobile app to track their progress and record a weekly sample. Unlike hierarchical models, components in CTT can be introduced in any order based on individual needs, making it flexible and personalized

Non-Hierarchical Conversation Training Therapy (CTT)

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smoking
• Diagnosis of either primary muscle tension dysphonia of the hyperadducted type or benign vocal fold lesions.
• No neuro-laryngologic or age-related vocal fold changes (e.g., atrophy)
• No history of voice therapy or voice surgery in the last year
• No history of other serious chronic medical conditions that may affect voice (per patient report), Normal hearing (determined by pure tone audiometry), stimulable and appropriate for behavioral voice intervention as determined by a voice-specialized speech-language pathologist and laryngologist,
• Willingness to attend all therapeutic interventions and follow-up sessions
• Willingness to use a smartphone to record practice

You may not qualify if:

• History of voice therapy or voice surgery in the last year
• Serious chronic medical condition that may affect voice (per patient report)
• Abnormal hearing ability (despite appropriate amplification)
• Other laryngeal disorders not attributed to primary MTD and benign vocal fold lesions,
• Not stimulable or inappropriate for behavioral voice intervention as determined by a voice-specialized speech-language pathologist and laryngologist
• Unwillingness to attend therapeutic intervention and follow-up sessions
• Unwillingness to use a smartphone to record practice
• Pregnant women
• Prisoners
• Cognitive impairment or impaired decision-making capacity

Sponsors & Collaborators

• Emory University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Emory Voice Center at Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amanda Gillespie, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Gillespie, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects will be assigned based on a stratified block randomization based on diagnosis (MTD, lesions), severity (mild, moderate, severe), and sex

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 16, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Datasets will be uploaded to OSF within 6 months of their collection, beginning 4 months after the award begins
• Access Criteria: Acoustic, aerodynamic, visual, and auditory perceptual and patient-reported outcomes data will be made available on the Open Science Framework Repository. This repository is an open-access, free platform designed for data preservation and sharing. De-identified datasets and metadata will be publicly accessible through this repository. PI will maintain up-to-date ORCID records with persistent unique identifiers such as DOIs for publications and funder IDs to assist findability. DOIs will be searchable in the Open Science Framework Repository.

Locations

US (1)