An interventional study of Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing in Vestibular Function Tests and Dizziness, sponsored by Otolith Labs. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Otolith Labs · Not applicable, Interventional, and Prevention
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.
Vestibular disorders can be difficult to diagnose and can vary in symptoms and fluctuate in severity. It is typically hard to determine which vestibular system (left/right) might be causing the vestibular disorder, as both sides normally work in unison. Testing the vestibular function in each side (left/right) of a patient is typically done with "caloric testing", which allows testing the left and right vestibular systems separately. However, it leads to nausea in most patients, and part of the clinical test is spent waiting for the patient to recover. Many patients undergoing caloric testing experience nausea to the point that some patients cannot complete the test, while others need a long period of time to recover from the nausea and dizziness induced by the testing. While it is hoped that this project will ultimately help establish the effectiveness of the transcranial vibration system for a range of vestibular disorders, we choose caloric testing for an initial assessment because it is performed daily in the clinic, it is easy to administer, and there is very little controversy about its use.
Specific Aims: Using Otolith Labs' device, we wish:
To determine if subjects undergoing caloric testing treated with the device
Objectives:
Primary: To demonstrate the efficacy of a bone conduction device at preventing nausea in subjects undergoing vestibular (particularly caloric) testing, as measured by the reduction from baseline of symptoms associated with (caloric)-testing
Secondary: To show that the use of the bone conduction device does not change the clinical measures obtained by vestibular caloric testing.
285 studies on the registry are indexed under Dizziness; 62 are open to participants now.
This study's enrollment of 39 is below the median of 50 across 208 interventional studies indexed under Dizziness.
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Exclusion Criteria:
Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing
Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing
Transcranial vibrating system will be on then off (or off then on in a random order) during a repeated application of the "calorics testing" stimulus, i.e. warm or cold water irrigated in the left (then right) ear canal. The effect of the vibrating system on 1) resulting dizziness and nausea often experienced by patients and 2) clinical parameters measured by caloric testing will be quantified.
Nausea and dizziness
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 vibration system.
Time frame: VAS administered ten minutes post-caloric testing; data will be analyzed upon study completion, estimated to last 6 weeks
Vestibular testing outcomes
Nystagmus associated with caloric testing (the primary clinical measure derived from caloric testing) will be compared, in the "with device" and "without device" conditions.
Time frame: Vestibular clinical measures will be analyzed by a clinician upon study completion, estimated to last 6 weeks.
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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