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临床试验/NCT02753179
NCT02753179已完成不适用

Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Frequency of covert-saccades

研究概览

简要总结

Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The objective of this study is to evaluate the potential functional benefice of these compensatory movements in a population of 20 patients with chronic bilateral areflexia, in a cross-sectional study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Bilateral Vestibular Hypofunction (BVH) with at least two of the tree following criteria
  • Mean peak slow phase velocity of 5°/s or less in bilateral bithermal (30 and 44°C) caloric irrigations
  • Pathologic Head-impulse test
  • VOR gain of <0.25 on rotatory chair tests
  • Disorder present for over 6 month
  • Comprehension of the experiments instructions
  • Patient consent

排除标准

  • Corrected Visual Acuity lower than 5/10
  • Other conditions leading to oscillopsia or ataxia
  • Oculomotor palsy, ocular instability in primary position
  • Cervical rachis pathology with instability
  • Cochlear Implants
  • Non-stabilized medical disease
  • Pregnant women
  • Patients under tutelage

结局指标

主要结局

Frequency of covert-saccades

时间窗: Day 0

Frequency of covert saccades corresponds to the total amount of covert-saccades divided by the total amount of head impulse tests multiplied by 100.

次要结局

  • Dynamic visual acuity(day 0)
  • Quality of life assessed with the Dizziness Handicap Inventory(Day 0)
  • Oscillopsia severity questionnaire score(day 0)
  • Latency of covert-saccades(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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