The Head Impulse Test in the Screening of Vestibular Function

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Clalit Health Services, Haifa and West Galilee
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01426932
First received: August 27, 2011
Last updated: June 27, 2013
Last verified: February 2012
  Purpose

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.


Condition Intervention
Vertigo
Other: Video recording of Head Impulse Test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Head Impulse Test in the Screening of Vestibular Function

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Sensitivity of the recorded HIT results in the prediction of the caloric test lateralization parameter [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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))


Secondary Outcome Measures:
  • Sensitivity of the bed-side HIT examination results in the prediction of the caloric test lateralization parameter [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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))

  • Specificity of the bed-side HIT examination results in the prediction of the caloric test lateralization parameter [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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))


Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Video recording of Head Impulse Test
    Video recording of Head Impulse Test
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Tertiary center patients

Criteria

Inclusion Criteria:

  • Age > 18 years
  • Videonystagmography(VNG) test battery is indicated for the diagnosis of dizziness or vertigo

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426932

Locations
Israel
Otoneurology Unit, Lin Medical Center, 35 Rotchild Avenue
Haifa, Israel, 35152
Sponsors and Collaborators
Meir Medical Center
Clalit Health Services, Haifa and West Galilee
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01426932     History of Changes
Other Study ID Numbers: HITVNG
Study First Received: August 27, 2011
Last Updated: June 27, 2013
Health Authority: Israel: clalit health services

Keywords provided by Meir Medical Center:
Vestibular Function Tests
Caloric Test
Electronystagmography
Prediction

ClinicalTrials.gov processed this record on October 22, 2014