vHIT- and VOG-model for Bilateral Vestibular NeuronitisNCT04783610
Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome.
A study testing Ethanol in people with vHIT- and VOG-model for Bilateral Vestibular Neuronitis, run by Turku University Hospital.
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- vHIT- and VOG-model for Bilateral Vestibular Neuronitis
- What is being tested?
- Ethanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no previous ear diseases
- normal hearing
- no signs of alcohol dependence (6 points or less in AUDIT-questionnaire)
Who cannot join
- previous ear diseases
- abnormal hearing
- signs of alcohol dependence (7 points or more in AUDIT-questionnaire)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome: Similarities in VHIT and VOG Data.
The purpose of the study is to create a vHIT- and VOG-model for bilateral vestibular neuronitis, via ethanol administration in healthy human subjects.
Read the 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.
- Being tested
- Ethanol
- Keywords
- vHIT, vestibular neuronitis, VOG
- Medical subject headings
- Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolOther
Ethanol will be administered via oral route.
| Study group | Role | What they receive |
|---|---|---|
| Study subjects for vHIT- and VOG-measurements | Experimental | Each study subject is his/hers own comparator at different phases of ethanol consumption. Receives: Other: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 hours or 1 work day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for vHIT- and VOG-model for Bilateral Vestibular NeuronitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jussi Sarin, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783610
- Sponsor's protocol ID
- 202130409
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethanol-induced Vestibular Dysfunction as a Model for Bilateral Vestibular Syndrome: Similarities in VHIT and VOG Data.
- ClinicalTrials.gov ID
- NCT04783610
- Acronym / sponsor ID
- 202130409
- Keywords
- vHIT, vestibular neuronitis, VOG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- May 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study subjects for vHIT- and VOG-measurements | Experimental | Other: EthanolEach study subject is his/hers own comparator at different phases of ethanol consumption. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- no previous ear diseases
- normal hearing
- no signs of alcohol dependence (6 points or less in AUDIT-questionnaire)
Key exclusion criteria (3 listed)
- previous ear diseases
- abnormal hearing
- signs of alcohol dependence (7 points or more in AUDIT-questionnaire)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthanolEthanol will be administered via oral route. | Other | Study subjects for vHIT- and VOG-measurements |
Primary outcome
Ethanol-induced vestibular function decline as measured with vHIT-gain-value-measurements.
Time frame: 5 hours or 1 work day
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol in people with vHIT- and VOG-model for Bilateral Vestibular Neuronitis, run by Turku University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jussi Sarin, Ph.D. (+35823130409, jussar@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ethanol-induced vestibular function decline as measured with vHIT-gain-value-measurements. (time frame: 5 hours or 1 work day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.