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NCT07145086 · ClinicalTrials.gov registry record · Phase 3
Translaryngeal Vibration for Hyperfunctional Voice Disorders
A Phase 3 study of Dysphonia and Muscle Tension Dysphonia, sponsored by Texas Christian University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07145086: Recruiting Phase 3 study of Dysphonia and Muscle Tension Dysphonia, sponsored by Texas Christian University.
NCT07145086 is a Phase 3 study of Dysphonia and Muscle Tension Dysphonia that is actively recruiting participants, run by Texas Christian University. The registered enrollment target is 30 participants, below the 58-participant average among 7 other Dysphonia trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07145086, a Phase 3 study of Dysphonia and Muscle Tension Dysphonia, is actively recruiting participants, sponsored by Texas Christian University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The Voice Handicap Index (VHI) is a self-assessment tool used to evaluate how a voice disorder impacts a person's daily life, encompassing functional, physical, and emotional aspects. It helps quantify the perceived handicap caused by a voice problem, aiding in diagnosis, treatment planning, and assessing treatment effectiveness. The VHI consists of 30 questions, divided into three subscales, with scores ranging from 0 to 120, where higher scores indicate a greater perceived handicap
Conditions Studied
Interventions
- BEHAVIORAL Voice therapy with vibration
Study Locations (1)
Texas
- Texas Christian University - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 3 |
What NCT07145086 shows while recruiting
NCT07145086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 58-participant average among 7 other Dysphonia trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Dysphonia appearing as the primary indexed condition, and to 1 intervention - of which Voice therapy with vibration is the first listed.
NCT07145086 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07145086 about?
NCT07145086 is a clinical study titled "Translaryngeal Vibration for Hyperfunctional Voice Disorders". 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 ...
What is the current status of trial NCT07145086?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2024-09-01. Estimated completion is 2027-08-31.
What conditions does trial NCT07145086 study?
This clinical trial studies the following conditions: Dysphonia, Muscle Tension Dysphonia.
What interventions are being tested in trial NCT07145086?
The interventions under investigation include: Voice therapy with vibration (BEHAVIORAL).
Who is sponsoring clinical trial NCT07145086?
This trial is sponsored by Texas Christian University, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07145086 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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