An interventional study of Ethanol in vHIT- and VOG-model for Bilateral Vestibular Neuronitis, sponsored by Turku University Hospital. Status unknown. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-05.
Sponsored by Turku University Hospital · Not applicable, Interventional, and Diagnostic
The purpose of the study is to create a vHIT- and VOG-model for bilateral vestibular neuronitis, via ethanol administration in healthy human subjects.
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.
34 studies on the registry are indexed under Vestibular Neuronitis; 4 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 27 interventional studies indexed under Vestibular Neuronitis.
Browse Vestibular Neuronitis studies →Turku University Hospital is the lead sponsor of 287 studies on the registry; 67 are open to participants now.
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Exclusion Criteria:
Each study subject is his/hers own comparator at different phases of ethanol consumption.
Other: Ethanol
Ethanol will be administered via oral route.
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.
Time frame: 5 hours or 1 work day
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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