The Head Impulse Test in the Screening of Vestibular Function
1 other identifier
observational
50
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2011
CompletedFirst Posted
Study publicly available on registry
September 1, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 1, 2013
February 1, 2012
2.2 years
August 27, 2011
June 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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))
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))
18 months
Secondary Outcomes (2)
Sensitivity of the bed-side HIT examination results in the prediction of the caloric test lateralization parameter
18 months
Specificity of the bed-side HIT examination results in the prediction of the caloric test lateralization parameter
18 months
Interventions
Video recording of Head Impulse Test
Eligibility Criteria
Tertiary center patients
You may qualify if:
- Age \> 18 years
- Videonystagmography(VNG) test battery is indicated for the diagnosis of dizziness or vertigo
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Otoneurology Unit, Lin Medical Center, 35 Rotchild Avenue
Haifa, 35152, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2011
First Posted
September 1, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
July 1, 2013
Record last verified: 2012-02