VertigoNCT01426932
The Head Impulse Test in the Screening of Vestibular Function
An observational study of Vertigo, run by Meir Medical Center at 1 site in Israel.
Trial summary
The alternate binaural bithermal caloric test (ABBT) is a well established examination in the evaluation of the dizzy patient. ABBT is useful in detecting the side of peripheral vestibulopathy by stimulating each ear separately, it contributes to the diagnosis of bilateral vestibular involvement when all responses to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertigo
- What is being tested?
- Video recording of Head Impulse Test
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Dec 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary center patients
Who may be able to join
- Age > 18 years
- Videonystagmography(VNG) test battery is indicated for the diagnosis of dizziness or vertigo
Who cannot join
- Signs of retrocochlear lesion or central vestibular pathology in bed-side otoneurological examination or audiometry or ENG/VNG
- Age < 18 years
- Otitis externa
- Otitis media
- Tympanic membrane perforation
- Status Post Mastoidectomy
- Limitations of neck movements in the horizontal plain
Trial locations and contacts
1 site in 1 country.
Israel1 site
Otoneurology Unit, Lin Medical Center, 35 Rotchild Avenue
Haifa, 35152
About this study
The alternate binaural bithermal caloric test (ABBT) is a well established examination in the evaluation of the dizzy patient. ABBT is useful in detecting the side of peripheral vestibulopathy by stimulating each ear separately, it contributes to the diagnosis of bilateral vestibular involvement when all responses to cold and warm stimuli are reduced, and adds to the differentiation of peripheral from central vestibular involvement by measuring the fixation-induced inhibition of the caloric response. In spite of these benefits, ABBT is the most time-consuming part of the electronystagmography/Videonystagmography (ENG/VNG) test battery, and frequently causes significant inconvenience to the patient due to the repeated extreme vestibular stimuli.
The head impulse test (HIT) assesses vestibular function by brisk, passive rotations of the head in the plane of the examined semicircular canals. Whenever the vestibulo-ocular reflex (VOR) is deficient, this maneuver would produce catch-up saccades aiming to the re-fixation of the eyes on the target. Hence, both residual VOR and catch-up saccades act synergistically to stabilize gaze. The HIT requires only several minutes and might cause minimal discomfort only.
The study hypothesis is that the HIT recorded by standard VNG equipment of the VNG system would provide diagnostic information on the side of vestibular involvement matching that of the ABBT.
- Conditions
- Vertigo
- Being tested
- Video recording of Head Impulse Test
- Keywords
- Vestibular Function Tests, Caloric Test, Electronystagmography, Prediction
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video recording of Head Impulse TestOther
Video recording of Head Impulse Test
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the recorded HIT results in the prediction of the caloric test lateralization parameter
Sensitivity would be calculated according to the following formula: Number of participants in whom catch-up saccades would be recorded and caloric test lateralization would be greater than 25% divided by the sum of number of participants in whom catch-up saccades would be recorded and caloric test lateralization would be greater than 25% plus the number of participants in whom no catch-up saccades would be recorded and caloric test lateralization would be greater than 25% (number of true positives /(number of true positives + number of false negatives))
Measured: 18 months
Specificity of the VNG recorded HIT results in the prediction of the caloric test lateralization parameter
Specificity would be calculated according to the following formula: Number of participants in whom no catch-up saccades would be recorded and caloric test lateralization would be smaller than 25% divided by the sum of number of participants in whom no catch-up saccades would be recorded and caloric test lateralization would be smaller than 25% plus the number of participants in whom catch-up saccades would be recorded and caloric test lateralization would be smaller than 25% (number of true negatives /(number of true negatives + number of false positives))
Measured: 18 months
Secondary outcomes (2)
Sensitivity of the bed-side HIT examination results in the prediction of the caloric test lateralization parameter
Sensitivity = Number of participants in whom catch-up saccades would be diagnosed in the HIT bed-side examination and caloric test lateralization would be greater than 25% divided by the sum of number of participants in whom catch-up saccades would be diagnosed in the HIT bed-side examination and caloric test lateralization would be greater than 25% plus the number of participants in whom no catch-up saccades would be diagnosed and caloric test lateralization would be greater than 25% (number of true positives /(number of true positives +number of false negatives))
Measured: 18 months
Specificity of the bed-side HIT examination results in the prediction of the caloric test lateralization parameter
Specificity would be calculated according to the following formula: Number of participants with no catch-up saccades in the HIT bed-side examination and caloric test lateralization smaller than 25% divided by the sum of number of participants in with catch-up saccades in the HIT bed-side examination and caloric test lateralization smaller than 25% plus the number of participants with catch-up saccades in the HIT bed-side examination and caloric test lateralization smaller than 25% (number of true negatives /(number of true negatives + number of false positives))
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services, Haifa and West Galilee
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426932
- Sponsor's protocol ID
- HITVNG
- Status last verified
- Feb 2012
- First submitted
- 27 Aug 2011
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Head Impulse Test in the Screening of Vestibular Function
- ClinicalTrials.gov ID
- NCT01426932
- Acronym / sponsor ID
- HITVNG
- Conditions
- Vertigo
- Keywords
- Vestibular Function Tests, Caloric Test, Electronystagmography, Prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services, Haifa and West Galilee
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 1 Sep 2011 (estimated)
- 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 alternate binaural bithermal caloric test (ABBT) is a well established examination in the evaluation of the dizzy patient. ABBT is useful in detecting the side of peripheral vestibulopathy by stimulating each ear separately, it contributes to the diagnosis of bilateral vestibular involvement when all responses to cold and warm stimuli are reduced, and adds to the differentiation of peripheral from central vestibular involvement by measuring the fixation-induced inhibition of the caloric response. In spite of these benefits, ABBT is the most time-consuming part of the electronystagmography/Videonystagmography (ENG/VNG) test battery, and frequently causes significant inconvenience to the patient due to the repeated extreme vestibular stimuli.
The head impulse test (HIT) assesses vestibular function by brisk, passive rotations of the head in the plane of the examined semicircular canals. Whenever the vestibulo-ocular reflex (VOR) is deficient, this maneuver would produce catch-up saccades aiming to the re-fixation of the eyes on the target. Hence, both residual VOR and catch-up saccades act synergistically to stabilize gaze. The HIT requires only several minutes and might cause minimal discomfort only.
The study hypothesis is that the HIT recorded by standard VNG equipment of the VNG system would provide diagnostic information on the side of vestibular involvement matching that of the ABBT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary center patients
Key inclusion criteria (2 listed)
- Age > 18 years
- Videonystagmography(VNG) test battery is indicated for the diagnosis of dizziness or vertigo
Key exclusion criteria (7 listed)
- Signs of retrocochlear lesion or central vestibular pathology in bed-side otoneurological examination or audiometry or ENG/VNG
- Age < 18 years
- Otitis externa
- Otitis media
- Tympanic membrane perforation
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 |
|---|---|---|
| Video recording of Head Impulse TestVideo recording of Head Impulse Test | Other | – |
Primary outcome
Sensitivity of the recorded HIT results in the prediction of the caloric test lateralization parameter
Time frame: 18 months
Sensitivity would be calculated according to the following formula: Number of participants in whom catch-up saccades would be recorded and caloric test lateralization would be greater than 25% divided by the sum of number of participants in whom catch-up saccades would be recorded and caloric test lateralization would be greater than 25% plus the number of participants in whom no catch-up saccades would be recorded and caloric test lateralization would be greater than 25% (number of true positives /(number of true positives + number of false negatives))
Specificity of the VNG recorded HIT results in the prediction of the caloric test lateralization parameter
Time frame: 18 months
Specificity would be calculated according to the following formula: Number of participants in whom no catch-up saccades would be recorded and caloric test lateralization would be smaller than 25% divided by the sum of number of participants in whom no catch-up saccades would be recorded and caloric test lateralization would be smaller than 25% plus the number of participants in whom catch-up saccades would be recorded and caloric test lateralization would be smaller than 25% (number of true negatives /(number of true negatives + number of false positives))
2 secondary outcomes
Sensitivity of the bed-side HIT examination results in the prediction of the caloric test lateralization parameter
Time frame: 18 months
Specificity of the bed-side HIT examination results in the prediction of the caloric test lateralization parameter
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo, run by Meir Medical Center at 1 site in Israel.
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 2 inclusion and 7 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 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the recorded HIT results in the prediction of the caloric test lateralization parameter (time frame: 18 months). The study lists 2 primary outcomes in all. 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 1 Jul 2013.