Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes (NCT07176988) | Clinical Trial Compass
RecruitingNot Applicable
Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes
United States120 participantsStarted 2025-09-03
Plain-language 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.
Who can participate
Age range
16 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Voice Handicap Index-10 (VHI-10) score
Timeframe: 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
2
Change in vowel space
Timeframe: 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.