NCT07145086 Translaryngeal Vibration for Hyperfunctional Voice Disorders
| NCT ID | NCT07145086 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Texas Christian University |
| Condition | Dysphonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 30 participants in total. It began in 2024-09-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Contemporary treatments for hyperfunctional voice disorders such as muscle tension dysphonia (MTD) are effective but typically do not restore voice handicap or voice function to normal thresholds. Recent reports of vibration as a voice therapy modality have been published, but many questions remain about the efficacy of this tool. The current project addresses these problems through a blinded and randomized controlled trial to investigate the efficacy of local translaryngeal vibration for MTD and the dose-response relationship of this modality when compared to treatment without vibration.
Eligibility Criteria
Inclusion Criteria: * a) diagnosis by an otolaryngologist of hyperfunctional dysphonia (MTD) without benign mid-membranous lesion (i.e., primary MTD or non-phonotraumatic hyperfunction) with and a recommendation for voice therapy, ((b) confirmation of dysphonia by a comprehensive voice evaluation conducted by a speech-language pathologist with experience in the evaluation and treatment of voice disordered populations, (c) to prevent floor effects of our primary outcome variable, participants will be required to exhibit a pre-treatment VHI score of \>20, as this is the upper range for normal cutoff values in studies which have demonstrated high sensitivity and specificity for this tool (Behlau et al., 2016), (d) 18 years of age or older, (e) no history of local vibration therapy as part of a rehabilitation treatment program. Exclusion Criteria: * Unable to receive vibration to neck area
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07145086 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dysphonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07145086 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 30 participants.
Is NCT07145086 currently recruiting?
Yes, NCT07145086 is actively recruiting participants. Contact the research team at c.watts@tcu.edu for enrollment information.
Where is the NCT07145086 trial being conducted?
This trial is being conducted at Fort Worth, United States.
Who is sponsoring the NCT07145086 clinical trial?
NCT07145086 is sponsored by Texas Christian University. The trial plans to enroll 30 participants.