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Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome.

Primary Purpose

vHIT- and VOG-model for Bilateral Vestibular Neuronitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ethanol
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for vHIT- and VOG-model for Bilateral Vestibular Neuronitis focused on measuring vHIT, vestibular neuronitis, VOG

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • no previous ear diseases
  • normal hearing
  • no signs of alcohol dependence (6 points or less in AUDIT-questionnaire)

Exclusion Criteria:

  • previous ear diseases
  • abnormal hearing
  • signs of alcohol dependence (7 points or more in AUDIT-questionnaire)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Study subjects for vHIT- and VOG-measurements

    Arm Description

    Each study subject is his/hers own comparator at different phases of ethanol consumption.

    Outcomes

    Primary Outcome Measures

    Ethanol-induced vestibular function decline as measured with vHIT-gain-value-measurements.
    Video head impulse test measures the speed of eye movement as well as head movement (degrees per second, taken from 60 ms time interval from the beginning of head movement), the latter being produced by the investigator. The ratio of a sudden horizontal head movement and a rapid eye movement towards the opposite direction (as the subject is trying to fixate gaze straight ahead) is referred as gain value. With succeeding measurements during ethanol consumption, gain values will be recorded. The data contains vHIT gain -values at base level, without ethanol consumption, as well as during and after ethanol consumption. The most important tool in statistical analysis of the data is repeated measures analysis of variance (rm ANOVA). This allows each test subject to act as his/hers own control, as succeeding measurements are being compared to the base line values. The statistical significance will be set at the p< 0.05 level.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2021
    Last Updated
    March 4, 2021
    Sponsor
    Turku University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04783610
    Brief Title
    Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome.
    Official Title
    Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome: Similarities in VHIT and VOG Data.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    October 2021 (Anticipated)
    Study Completion Date
    October 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Turku University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to create a vHIT- and VOG-model for bilateral vestibular neuronitis, via ethanol administration in healthy human subjects.
    Detailed Description
    Ethanol administration has an effect on vestibular function, measurable with video head impulse test (vHIT)- and vestibulo-oculography (VOG)-methods. The purpose of the study is to create a vHIT- and VOG-model for bilateral vestibular neuronitis, a disease with difficult diagnostics, via ethanol administration in healthy human subjects. As subjects are consuming ethanol via oral route, vHIT-measurements and VOG-measurements (slow and rapid eye movement recordings) are being recorded in order to measure the change in vestibular function. During approx. 5 hours, 4 vHIT measurements will take place, while subjects ingest ethanol towards 1 per mille levels, measured via alcoholmeter. Necessary precautions include strict exclusion criteria regarding health of the subjects and also comprehensive preparedness for management of allergic reactions and other unusual phenomena related to alcohol consumption.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    vHIT- and VOG-model for Bilateral Vestibular Neuronitis
    Keywords
    vHIT, vestibular neuronitis, VOG

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study subjects for vHIT- and VOG-measurements
    Arm Type
    Experimental
    Arm Description
    Each study subject is his/hers own comparator at different phases of ethanol consumption.
    Intervention Type
    Other
    Intervention Name(s)
    Ethanol
    Intervention Description
    Ethanol will be administered via oral route.
    Primary Outcome Measure Information:
    Title
    Ethanol-induced vestibular function decline as measured with vHIT-gain-value-measurements.
    Description
    Video head impulse test measures the speed of eye movement as well as head movement (degrees per second, taken from 60 ms time interval from the beginning of head movement), the latter being produced by the investigator. The ratio of a sudden horizontal head movement and a rapid eye movement towards the opposite direction (as the subject is trying to fixate gaze straight ahead) is referred as gain value. With succeeding measurements during ethanol consumption, gain values will be recorded. The data contains vHIT gain -values at base level, without ethanol consumption, as well as during and after ethanol consumption. The most important tool in statistical analysis of the data is repeated measures analysis of variance (rm ANOVA). This allows each test subject to act as his/hers own control, as succeeding measurements are being compared to the base line values. The statistical significance will be set at the p< 0.05 level.
    Time Frame
    5 hours or 1 work day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: no previous ear diseases normal hearing no signs of alcohol dependence (6 points or less in AUDIT-questionnaire) Exclusion Criteria: previous ear diseases abnormal hearing signs of alcohol dependence (7 points or more in AUDIT-questionnaire)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jussi Sarin, Ph.D.
    Phone
    +35823130409
    Email
    jussar@utu.fi

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome.

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