NCT01426932

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 1, 2013

Status Verified

February 1, 2012

Enrollment Period

2.2 years

First QC Date

August 27, 2011

Last Update Submit

June 27, 2013

Conditions

Keywords

Vestibular Function TestsCaloric TestElectronystagmographyPrediction

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations