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

August 27, 2011
June 27, 2013
October 2011
December 2013   (final data collection date for primary outcome measure)
  • 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))
Same as current
Complete list of historical versions of study NCT01426932 on ClinicalTrials.gov Archive Site
  • 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))
Same as current
Not Provided
Not Provided
 
The Head Impulse Test in the Screening of Vestibular Function
The Head Impulse Test in the Screening of Vestibular Function

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Tertiary center patients

Vertigo
Other: Video recording of Head Impulse Test
Video recording of Head Impulse Test
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01426932
HITVNG
No
Meir Medical Center
Meir Medical Center
Clalit Health Services, Haifa and West Galilee
Not Provided
Meir Medical Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP