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临床试验/NCT01426932
NCT01426932
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不适用

The Head Impulse Test in the Screening of Vestibular Function

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 50 人2011年10月
适应症Vertigo

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Vertigo
发起方
Meir Medical Center
入组人数
50
试验地点
1
主要终点
Sensitivity of the recorded HIT results in the prediction of the caloric test lateralization parameter
最后更新
12年前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2011年10月
结束日期
2013年12月
最后更新
12年前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

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

排除标准

  • 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

结局指标

主要结局

Sensitivity of the recorded HIT results in the prediction of the caloric test lateralization parameter

时间窗: 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

时间窗: 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))

次要结局

  • 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)

研究点 (1)

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