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Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing

NCT03618199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-02-06

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    collaborator OTHER

  • Otolith Labs

    lead INDUSTRY

Principal Investigators

  • David J Eisenman, MD · University of Maryland, Baltimore

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2022-08-22
Completion
2022-08-22
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03618199 on ClinicalTrials.gov