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

vHIT- and VOG-model for Bilateral Vestibular Neuronitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04783610
• Other study ID #: 202130409
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: October 2021

Study information

• Verified date: March 2021
• Source: Turku University Hospital
• Contact: Jussi Sarin, Ph.D.
• Phone: +35823130409
• Email: jussar[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Vestibular Neuronitis
• vHIT- and VOG-model for Bilateral Vestibular Neuronitis

Intervention

Other:
• Ethanol
Ethanol will be administered via oral route.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 hours or 1 work day