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NCT03618199 · ClinicalTrials.gov registry record · NA
Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
A NA study, sponsored by Otolith Labs.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT03618199: Completed NA study, sponsored by Otolith Labs.
NCT03618199 is a NA study that has completed, run by Otolith Labs. The registered enrollment target is 39 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
NCT03618199, a NA study, has completed, sponsored by Otolith Labs.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
Vestibular disorders are among the most common causes of disability in society. Vestibular dysfunction affects over one third of the population over the age of 40 and a significant percentage of the younger population. Vestibular disorders have a dramatic impact on daily life impacting work, relationships, and even activities of daily living. Diagnosis of vestibular disorders is often facilitated by functional vestibular tests. The most common of these tests is videonystagmography, during a critical portion of which, the "caloric test," warm and cool stimuli are presented in the outer ears to stimulate the inner ear vestibular system. The vertigo produced by caloric stimulation not uncommonly results in nausea, and sometimes vomiting, sometimes to the point of not being able to complete the test protocol. In this project we examine a device that has shown promise and might be beneficial for improving the testing for vestibular disorders. We hypothesize that with this device, the nausea associated with caloric testing will be significantly reduced when the device is used, while it will not change the results of the test in a statistically significantly manner. To date, the device has only been systematically tested on healthy volunteers.
Primary Outcome
Visual Analog Scales (VAS, adapted from "Visual Vertigo Analogue Scale" for dizziness and "Baxter Retching Faces (BARF)" for nausea) will be filled out by the subject ten minutes after each phase of the caloric testing, i.e. "with" and "without" the transcranial vibration system. Each phase of the caloric testing itself takes approximately 30 minutes. These Visual Analog Scales range from 0 to 10 (None to Agonizing). They will provide independent measures of the effectiveness of the transcranial
Interventions
- DEVICE Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2022-08-22 |
| Phase | NA |
What the finished NCT03618199 record still lists
NCT03618199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 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 1 intervention - of which Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing is the first listed.
NCT03618199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03618199 about?
NCT03618199 is a clinical study titled "Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing". Vestibular disorders are among the most common causes of disability in society. Vestibular dysfunction affects over one third of the population over the age of 40 and a significant percentage of the younger population. Vestibular disorders have a dramatic impact on daily life impacting work, relatio...
What is the current status of trial NCT03618199?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2018-10-01. Estimated completion is 2022-08-22.
What interventions are being tested in trial NCT03618199?
The interventions under investigation include: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing (DEVICE).
Who is sponsoring clinical trial NCT03618199?
This trial is sponsored by Otolith Labs, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03618199's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 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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