Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes

Not Applicable

Not yet recruiting

• Conditions: Dysphonia; Primary Muscle Tension Dysphonia (MTD)

• Registration Number: NCT07176988
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2025-08-18
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2029-04
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Voice Handicap Index-10 (VHI-10) score	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	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.
Change in vowel space	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 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

Secondary Outcome Measures

Name	Time	Method
Auditory- Perceptual severity	Baseline , 3 month, 6 month, 12 month	It is measured using the CAPE-V (Consensus Auditory-Perceptual Evaluation of Voice) scale, a standardized tool.; Raters (blinded speech-language pathologists) will score overall voice severity on a 0-100 mm visual analog scale-with 0 indicating no perceived disorder and 100 indicating extremely severe voice abnormality.; This rating captures a listener's perception of qualities like roughness, breathiness, strain, and overall voice quality.
Stroboscopic changes: Phase closure	Baseline, Post intervention (1 week), 3 month, 6 month, 12 month	Duration of open vs. closed phase during each vibratory cycle. Rated as: open phase dominates, equal, closed phase dominates Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Stroboscopic changes: Phase symmetry	Baseline, Post intervention (1 week), 3 month, 6 month, 12 month	Synchrony of left and right vocal fold movement. Rated as: symmetric or asymmetric Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Stroboscopic changes: Regularity percentage	Baseline, Post intervention (1 week), 3 month, 6 month, 12 month	Consistency of vibratory cycles over time. Expressed as % of time vibration is regular Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Aerodynamic changes: Average airflow in speech	Baseline, Post intervention (1 week), 3 month, 6 month, 12 month	Average airflow in speech - measures how much air passes through the vocal folds per second during phonation (typically in liters/second or mL/second). Abnormal airflow can indicate vocal fold dysfunction, such as incomplete closure or excessive strain.; This data will be collected using the Phonatory Aerodynamic System 6600 (PAS) by PENTAX, a specialized tool for assessing voice aerodynamics. The PAS system uses a mask and microphone setup to capture airflow and sound pressure during structured speech tasks.
Aerodynamic changes: Average number of breaths	Baseline, Post intervention (1 week), 3 month, 6 month, 12 month	Average number of breaths - counts how many breaths a speaker takes during a speech task. Higher breath counts may reflect inefficient voice use or reduced respiratory support.; This data will be collected using the Phonatory Aerodynamic System 6600 (PAS) by PENTAX, a specialized tool for assessing voice aerodynamics. The PAS system uses a mask and microphone setup to capture airflow and sound pressure during structured speech tasks.
Aerodynamic changes: Average speaking duration	Baseline, Post intervention (1 week), 3 month, 6 month, 12 month	Speaking duration is how long it takes the person to speak the entire passage. This data will be collected using the Phonatory Aerodynamic System 6600 (PAS) by PENTAX, a specialized tool for assessing voice aerodynamics. The PAS system uses a mask and microphone setup to capture airflow and sound pressure during structured speech tasks.
Adherence	Baseline, end of study (12 month)	Practice will be analyzed for frequency of practice per week
Practice fidelity	Baseline, end of study (12 month)	Practice fidelity will be assessed via analysis of audio-recordings for presence/absence of negative practice and type of practice (i.e. conversation, monology, recitation, reading aloud).
Stroboscopic changes: Glottal Closure	Baseline, Post intervention (1 week), 3 month, 6 month, 12 month	Visual inspection during phonation. Described as: complete, anterior gap, posterior gap, hourglass, spindle, irregular, incomplete.; Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Stroboscopic changes: Amplitude	Baseline, Post intervention (1 week), 3 month, 6 month, 12 month	Observed lateral movement of vocal folds. Subjectively rated as reduced, normal, or excessive. Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Stroboscopic changes: Mucosal Wave	Baseline, Post intervention (1 week), 3 month, 6 month, 12 month	Magnitude of mucosal membrane during vibration. Scored on a 0-10 scale based on visibility and extent Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Stroboscopic changes: Free edge contour	Baseline, Post intervention (1 week), 3 month, 6 month, 12 month	Shape of vocal fold edges during vibration. Rated as: normal, convex, concave, irregular, or rough Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.

Trial Locations

Locations (1)

Emory Voice Center at Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States