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

Turku University Hospital (TYKS)

Status: Unknown

Conditions: vHIT- and VOG-model for Bilateral Vestibular Neuronitis

Treatments: Other: Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT04783610

202130409

Details and patient eligibility

About

The purpose of the study is to create a vHIT- and VOG-model for bilateral vestibular neuronitis, via ethanol administration in healthy human subjects.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Study subjects for vHIT- and VOG-measurements

Experimental group

Description:

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

Treatment:

Other: Ethanol