Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03618199
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Otolith Labs

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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.

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 : October 1, 2018
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Nausea and dizziness [ Time Frame: 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.


  2. Vestibular testing outcomes [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject can speak and comprehend English.
  2. Subject can stand a strap placed on their head for an hour.

Exclusion Criteria:

  1. History of head injury within the last six months
  2. Presence of severe aphasia
  3. History of diagnosed neuropsychiatric disorders
  4. Documented neurodegenerative disorders
  5. Pregnancy [Female candidates will be asked if they are pregnant]
  6. History of Cerebrovascular disorders
  7. History of ear operation other than myringotomy and tube placement in the past

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618199


Contacts
Layout table for location contacts
Contact: Laura Castellon 410.328.2473 lcastellon@som.umaryland.edu

Locations
Layout table for location information
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Laura Castellon    410-328-2473    lcastellon@som.umaryland.edu   
Sponsors and Collaborators
Otolith Labs
University of Maryland
Investigators
Layout table for investigator information
Principal Investigator: David J Eisenman, MD University of Maryland

Layout table for additonal information
Responsible Party: Otolith Labs
ClinicalTrials.gov Identifier: NCT03618199     History of Changes
Other Study ID Numbers: Olith10101
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Keywords provided by Otolith Labs:
Caloric testing
vestibular nystagmography
VNG
Videonystagmography

Additional relevant MeSH terms:
Layout table for MeSH terms
Dizziness
Vertigo
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases