Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes

NCT ID: NCT07176988

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-03
• Study Completion Date: 2029-04-30

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.

Detailed Description

About 23 million Americans-roughly 1 in 13 people-suffer from voice problems at any given time. These issues can make it hard to speak clearly, lead to throat pain or fatigue, and affect daily life, work, and emotional well-being. The two most common types of voice problems are:

• Muscle tension dysphonia (MTD): when muscles in the throat are too tight during speaking.
• Benign vocal fold lesions: such as nodules or swelling on the vocal cords due to overuse or strain.

The most common treatment for these conditions is behavioral voice therapy, which involves working with a speech-language pathologist (SLP) to learn new ways to use the voice. However, over a third of patients drop out, and long-term success is uncertain. One major challenge is helping patients apply what they learn in therapy to their real-life conversations-a step often saved for the end of treatment or skipped entirely.

Traditional voice therapies often follow a strict step-by-step ("hierarchical") approach. Patients start with basic sounds or exercises and only work up to everyday speech later. But this method may not be the most effective, and many people struggle to use the new techniques outside the clinic.

To solve this problem, the research team developed a new method called Conversation Training Therapy (CTT). CTT flips the traditional approach: it begins with practicing clear, intentional speech in real conversation from the first session. This helps patients immediately apply new voice skills in real-life situations, which may lead to faster, more lasting results.

Studies have shown that CTT leads to meaningful improvements in voice-related quality of life both immediately and up to three months after therapy. It is now being used in national research studies and has gained recognition as a promising, evidence-based therapy. The current research will compare CTT to traditional methods over a full year, helping to answer important questions about what makes voice therapy work-and how to help more people benefit from it long-term.

Conditions

Dysphonia; Primary Muscle Tension Dysphonia (MTD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-Hierarchical Conversation Training Therapy (CTT)

Group Type: EXPERIMENTAL

Non Hierarchical method

Intervention Type: 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

Hierarchical Conversation Training Therapy (CTT-H)

Group Type: EXPERIMENTAL

Hierarchical method

Intervention Type: 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.

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Amanda Gillespie

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amanda Gillespie, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Voice Center at Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amanda Gillespie, PhD

Role: CONTACT

amanda.i.gillespie@emory.edu

404-778-3381

Facility Contacts

Amanda Gillespie, PhD

Role: primary

amanda.i.gillespie@emory.edu

404-778-3381

Other Identifiers

1R01DC022026-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009121

Identifier Type: -

Identifier Source: org_study_id