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

Sponsor

Otolith Labs (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03618199

Collaborator

University of Maryland, Baltimore (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibular Function Tests Dizziness	Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention 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.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 (Outcomes Assessor)

Masking Description:

Subject in both phases will immediately know whether the transcranial vibrating system is on. Analysis of outcomes (1-dizziness, 2-nausea, 3-clinical measures from vestibular nystagmography resulting from the caloric testing) will be blinded.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Efficacy of vibrating system on healthy volunteers	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.
Experimental: Efficacy of vibrating system on vestibular patients	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.

Arm

Intervention/Treatment

Experimental: Efficacy of vibrating system on healthy volunteers

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.

Experimental: Efficacy of vibrating system on vestibular patients

Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing

Outcome Measures

Primary Outcome Measures

Nausea and dizziness [VAS administered ten minutes post-caloric testing; data will be analyzed upon study completion, estimated to last 6 weeks]
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.
Vestibular testing outcomes [Vestibular clinical measures will be analyzed by a clinician upon study completion, estimated to last 6 weeks.]
Nystagmus associated with caloric testing (the primary clinical measure derived from caloric testing) will be compared, in the "with device" and "without device" conditions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

Otolith Labs
University of Maryland, Baltimore

Investigators

Principal Investigator: David J Eisenman, MD, University of Maryland, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Otolith Labs

ClinicalTrials.gov Identifier:

NCT03618199

Other Study ID Numbers:

Olith10101

First Posted:

Aug 7, 2018

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Otolith Labs

Caloric testing

vestibular nystagmography

VNG

Videonystagmography

Additional relevant MeSH terms:

Vertigo

Dizziness

Study Results

No Results Posted as of Mar 29, 2022