Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
Primary Purpose
Vestibular Function Tests, Dizziness
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing
Sponsored by
About this trial
This is an interventional prevention trial for Vestibular Function Tests focused on measuring Caloric testing, vestibular nystagmography, VNG, Videonystagmography
Eligibility Criteria
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
Sites / Locations
- University of MarylandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Efficacy of vibrating system on healthy volunteers
Efficacy of vibrating system on vestibular patients
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03618199
First Posted
July 24, 2018
Last Updated
June 12, 2023
Sponsor
Otolith Labs
Collaborators
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03618199
Brief Title
Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
Official Title
Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otolith Labs
Collaborators
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Function Tests, Dizziness
Keywords
Caloric testing, vestibular nystagmography, VNG, Videonystagmography
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
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.
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Efficacy of vibrating system on healthy volunteers
Arm Type
Experimental
Arm Title
Efficacy of vibrating system on vestibular patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nausea and dizziness
Description
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
Title
Vestibular testing outcomes
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toni White
Phone
410.328.2473
Email
toni.white@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Eisenman, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Castellon
Phone
410-328-2473
Email
lcastellon@som.umaryland.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
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