Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome.
NCT ID: NCT04783610
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2021-05-31
2021-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Study subjects for vHIT- and VOG-measurements
Each study subject is his/hers own comparator at different phases of ethanol consumption.
Ethanol
Ethanol will be administered via oral route.
Interventions
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Ethanol
Ethanol will be administered via oral route.
Eligibility Criteria
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Inclusion Criteria
* normal hearing
* no signs of alcohol dependence (6 points or less in AUDIT-questionnaire)
Exclusion Criteria
* abnormal hearing
* signs of alcohol dependence (7 points or more in AUDIT-questionnaire)
22 Years
ALL
Yes
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Jussi Sarin
Clinical Teacher in the Department of Otorhinolaryngology
Central Contacts
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Other Identifiers
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202130409
Identifier Type: -
Identifier Source: org_study_id
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