NCT07176988 · Emory University
Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes
What this study is about
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).
View original scientific description
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.
Interventions
OTHER
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.
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
Primary outcome measures
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
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
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 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Cognitive impairment or impaired decision-making capacity
Where
- Atlanta, Georgia
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2025 · Source of record for eligibility and locations