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

Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome: Similarities in VHIT and VOG Data.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04783610
Enrollment
10
Registered
2021-03-05
Start date
2021-05-31
Completion date
2021-10-31
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vHIT- and VOG-model for Bilateral Vestibular Neuronitis

Keywords

vHIT, vestibular neuronitis, VOG

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.

Interventions

OTHEREthanol

Ethanol will be administered via oral route.

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Ethanol-induced vestibular function decline as measured with vHIT-gain-value-measurements.5 hours or 1 work dayVideo 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.

Contacts

Primary ContactJussi Sarin, Ph.D.
jussar@utu.fi+35823130409

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026