Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-65
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Hierarchical method
Other interventionParticipants 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
Other interventionThe 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
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Non-Hierarchical Conversation Training Therapy (CTT)Experimental treatment 1 intervention
Group B: Hierarchical Conversation Training Therapy (CTT-H)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 treatment2
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
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.Secondary outcomes
1
Auditory- Perceptual severity
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.
Time frame
Baseline , 3 month, 6 month, 12 month2
Stroboscopic changes: Glottal Closure
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.
Time frame
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month3
Stroboscopic changes: Amplitude
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.
Time frame
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month4
Stroboscopic changes: Mucosal Wave
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.
Time frame
Baseline, Post intervention (1 week), 3 month, 6 month, 12 monthSponsors and contacts
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Emory University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov