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NCT03746509 · ClinicalTrials.gov registry record · NA
Laryngeal Vibration for Spasmodic Dysphonia
A NA study, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT03746509: Completed NA study, sponsored by University of Minnesota.
NCT03746509 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03746509, a NA study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study Summary
The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of people with spasmodic dysphonia (SD). This research addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with limited treatment options. A successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving the voice symptoms in SD. Specifically, the scientific yield by achieving the specific aims is threefold: First, it will elucidate the unknown neurophysiological mechanism behind laryngeal VTS by documenting the neural changes associated with VTS. Second, it will establish that VTS can improve voice quality in SD. Third, by documenting that laryngeal VTS yields long-term benefits on voice quality in SD patients, it would provide a solid basis for a clinical trial that needs to address open questions on optimal dosage and duration of VTS-based voice therapy, the magnitude of the therapeutic effect across adductor and abductor SD and its long term efficacy.
Primary Outcome
Smoothed Cepstral Peak Prominence (CPPS) is an indicator of voice quality. It is measured in decibels. CPPS was measured from the voice signals of each participant during each study visit, and relative CPPS was calculated before and after vibration was applied on the laryngeal muscles of the participants. An increase in CPPS value indicates an improvement in voice symptoms.
Interventions
- DEVICE Laryngeal Vibration (Treatment)
- DEVICE Laryngeal Vibration (Comparator)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-04-02 |
| Est. Completion | 2022-07-20 |
| Phase | NA |
What the finished NCT03746509 record still lists
NCT03746509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Laryngeal Vibration (Treatment) is the first listed.
NCT03746509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03746509 about?
NCT03746509 is a clinical study titled "Laryngeal Vibration for Spasmodic Dysphonia". The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of people with spasmodic dysphonia (SD). This research addresses a clinical need to develop a...
What is the current status of trial NCT03746509?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2019-04-02. Estimated completion is 2022-07-20.
What interventions are being tested in trial NCT03746509?
The interventions under investigation include: Laryngeal Vibration (Treatment) (DEVICE), Laryngeal Vibration (Comparator) (DEVICE).
Who is sponsoring clinical trial NCT03746509?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03746509's enrollment target sits among peer trials
42 1436th of 2000 higher than 555 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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