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

Study Overview
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Brief Summary
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Testing for vestibular dysfunction often induces dizziness and nausea, to the point that testing cannot be completed. The investigators will use a transcranial vibration system that has shown promise in improving comfort during testing for vestibular disorders. The investigators hypothesize that with this transcranial vibration system, the dizziness and nausea associated with caloric testing will be significantly reduced, while the clinical measures derived from the test will not be statistically significantly altered.

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

Conditions
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Vestibular Function Tests, Dizziness

Intervention / Treatment
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* Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject can speak and comprehend English. Subject can stand a strap placed on their head for an hour. Exclusion Criteria: History of head injury within the last six months Presence of severe aphasia History of diagnosed neuropsychiatric disorders Documented neurodegenerative disorders Pregnancy [Female candidates will be asked if they are pregnant] History of Cerebrovascular disorders History of ear operation other than myringotomy and tube placement in the past

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: First phase: test 20 subjects. They will undergo the caloric testing part of the standard vestibular testing, with and without our transcranial vibration system (10 with device on then off, 10 with device off then on) and will describe their state on a visual analog scale (both dizziness and nausea) at the end. Success is 1) substantially reduced dizziness ad nausea, 2) statistically unchanged clinical measures. If (and only if) the first phase is successful, we proceed to the second phase. Second phase: identical to first phase, but is conducted with patients coming in the clinic for vestibular testing. The order (device on first, or second) will be randomly assigned.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Efficacy of vibrating system on healthy volunteers<br> | Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing<br>* Transcranial vibrating system will be on then off (or off then on in a random order) during a repeated application of the calorics testingstimulus, 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.<br>|
| Experimental: Efficacy of vibrating system on vestibular patients<br> | Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing<br>* Transcranial vibrating system will be on then off (or off then on in a random order) during a repeated application of the calorics testingstimulus, 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Vestibular clinical measures will be analyzed by a clinician upon study completion, estimated to last 6 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caloric testing, vestibular nystagmography, VNG, Videonystagmography