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

NCT ID: NCT04783610

Last Updated: 2021-03-05

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2021-10-31

Brief Summary

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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

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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.

Conditions

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vHIT- and VOG-model for Bilateral Vestibular Neuronitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Ethanol

Intervention Type OTHER

Ethanol will be administered via oral route.

Interventions

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Ethanol

Ethanol will be administered via oral route.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jussi Sarin

Clinical Teacher in the Department of Otorhinolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jussi Sarin, Ph.D.

Role: CONTACT

+35823130409

Other Identifiers

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202130409

Identifier Type: -

Identifier Source: org_study_id

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