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临床试验/NCT03201328
NCT03201328已完成不适用

Prospective, Single Centre Cohort Study on the Impact of Binaural Audition on Postural Performance and Orientation in Healthy Subjects and Patients With Cochlear Implants.

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Modification of posturography parameters in the presence and absence of a de turning sound source

研究概览

简要总结

This is a prospective research study talking place at University hospital of Dijon and requiring the inclusion of 20 healthy subjects, 10 patients with unilateral cochlear implants and 10 patients with bilateral cochlear implants to carry out:

  • an audio-vestibular examination,
  • a videonystagmoscopic study,
  • a posturography study and
  • a movement study. The aim of the study is to evaluate the impact of binaural audition on postural performance and orientation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have provided written consent
  • Patients with health insurance cover
  • Age between 18 and 75 years old
  • For subjects with implants: unilateral or bilateral cochlear implants for more than one year
  • For healthy subjects: absence of known audio-vestibular disorders (deafness, vertigo)

排除标准

  • Patients dependent on an aid to move around (cane, wheelchair, crutch, ...)
  • Patients under guardianship
  • Pregnant women
  • Disability interfering with understanding or carrying out instructions
  • Associated sensory or motor disorders

结局指标

主要结局

Modification of posturography parameters in the presence and absence of a de turning sound source

时间窗: Baseline

Time to cover a distance of 3metres in a straight line and number of steps used

时间窗: Baseline

Presence of a sensation of rotation due to a turning sound source

时间窗: Baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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