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临床试验/NCT04907929
NCT04907929已完成不适用

Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年12月15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
9
试验地点
2
主要终点
Hospital Anxiety end Depression scale

研究概览

简要总结

It has been shown that in deaf people, cortical reorganisation occurs and can accelerate age-related cognitive decline. Therefore, even though a number of Cochlear Implantation Reference Centres are setting up tests to detect cognitive disorders, these remain global and not very specific to deafness. Similarly, auditory rehabilitation could make cognitive decline reversible and bring about major changes in the cognitive functioning of patients which will be decisive for the effectiveness of speech therapy and the effectiveness of implantation. Indeed, it has been shown that, in the deaf postlingual patient, less neuronal activity in the auditory cortex and a reallocation of the cortical regions dedicated to auditory processing to visual tasks took place. This could subsequently influence the outcome of the cochlear implant. The aim of this study is therefore to evaluate the effectiveness of targeted speech therapy aimed at cognitive reorganisation on post-implant gain.

研究设计

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

入排标准

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

入选标准

  • Men or Women ≥ 18 years of age coming for consultation at the implementation centre.
  • Subjects who can read and write French.
  • Patients who are candidates for cochlear implantation and who have not had any contraindication to the operation following the pre-implant assessment.
  • Ability to sign free and informed consent.
  • Subjects with a smartphone or laptop that allows access to the application

排除标准

  • Physical and cultural factors that may interfere with testing.

结局指标

主要结局

Hospital Anxiety end Depression scale

时间窗: 3 months

The HAD scale is an instrument to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension.

Grober et Buschke's test

时间窗: 3 months

This test assesses verbal memory and is composed of 16 items belonging to 16 different semantic categories. Indicative recall is used to check the efficiency of encoding and to dissociate memory disorders according to their type.

Door test

时间窗: 3 months

This test assesses visual-spatial episodic memory. It consists of presenting 24 pictures of doors to the patient. The patient must then recognise each of these doors in the presence of three distractors. It is divided into two parts which differ in terms of difficulty of recognition.

Verbal fluency test

时间窗: 3 months

This test consists of giving as many words as possible beginning with the same letter in two minutes (phonological fluencies) and as many words of the same category in two minutes (semantic fluencies). The interest of the study of fluencies is that they allow us to observe both the preferred functioning of patients (semantic vs. phonological) and other components such as working memory and semantic memory. The duration of this test is four minutes.

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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