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临床试验/NCT04183348
NCT04183348已完成不适用

Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss

Hospices Civils de Lyon4 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2020年7月6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
79
试验地点
4
主要终点
Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances

研究概览

简要总结

We recently developed a new Neuro-immersion system based on virtual reality and 3D (dimension) motion tracking. This tool makes it possible to evaluate and record the spatial localization performance of sounds and to highlight localization deficits in the three dimensions of space in deaf patients. Unfortunately, there is currently no suitable support to compensate for these localization deficits. However, the discomfort felt by the patients is clearly verbalized.

Thanks to the new virtual reality system, we are now able to develop a training protocol based on spatial sound localization tasks.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For all participants (patients and normal hearing adults):
  • Ages 18 and 65
  • Normal vision (with or without correction)
  • Able to understand experimental instructions
  • Member of the social security scheme
  • Informed of the study and signed the consent form
  • For hearing standards (NH):
  • - No hearing problems
  • For patients (SU, uIC and bIC):
  • Regular follow-up in the ENT (Ear, nose, and throat) department of the Edouard Herriot Hospital in Lyon or the Purpan Hospital, in Toulouse
  • Unilateral deep deafness (only for SU patients)
  • Holder of one Cochlear implant for more than one year (only for uIC patients)
  • Holder of the second Cochlear implant for more than one year (only for bIC patients)

排除标准

  • Oculomotor disorder
  • Bilateral vestibular areflexia
  • Neurological and/or psychiatric history
  • Person placed under legal protection, guardianship or trusteeship
  • Pregnant or nursing woman

结局指标

主要结局

Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances

时间窗: 1 day

* Explicit spatial auditory performances ("2d-D") is the combined (head) pointing error, corresponding to the distance in the space between the exact position of the target and the pointing of the subject. In other words, the more precise the subject becomes in his location of a sound source and the lower the value of "2d-D". * Implicit spatial auditory performances (called "RT") is the response time between the participant's response and the light point.

次要结局

  • Measure of the sensory feedback effect on spatial auditory performance by comparing the composite measure of the two training protocols(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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