Recruiting

Voice Treatment

Sponsor:

Emory University

Code:

NCT07176988

Conditions

Dysphonia

Primary Muscle Tension Dysphonia (MTD)

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

Interventions

Hierarchical method

Non Hierarchical method

Study Details

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)

Study ID

NCT07176988

Start date

Sep 3, 2025

Status verified date

Oct, 2025

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Non-Hierarchical Conversation Training Therapy (CTT)

experimental: Hierarchical Conversation Training Therapy (CTT-H)

Interventions

Hierarchical method

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.

Non Hierarchical method

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

Primary outcome measure

  • Change in Voice Handicap Index-10 (VHI-10) score [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Amanda Gillespie, PhD

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

Locations

Emory Voice Center at Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Amanda Gillespie, PhD

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

More Information

Sponsor

Emory University

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-20.