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临床试验/NCT06086041
NCT06086041招募中不适用

Predictive Factors of Hearing Rehabilitation After Cochlear Implant Surgery in Deaf Patients

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Identification of the predictive factors of hearing rehabilitation after cochlear implantation in severely to profoundly deaf adults.

研究概览

简要总结

The aim of this study is to display the predictive factors of hearing rehabilitation after cochlear implant surgery in severely to profoundly deaf adults.

详细描述

Cochlear implants are indicated in France in cases of severe to profound bilateral sensorineural hearing loss with an audiometric threshold of less than or equal to 50% speech discrimination in silence in the Fournier list (or equivalent) at 60 dB, in the free field, with well-fitted hearing aids. Cochlear implant represents a major advance in the management of severe to profoundly deaf patients and has also shown a benefit in the prevention of neurodegenerative diseases.

An average of 1800 cochlear implants are placed in France per year, 58% of which are placed in patients over 18 years of age.

The results of cochlear implants are in favour of a benefit in speech comprehension compared to hearing aids in cases of severe to profound deafness. However, there is a strong disparity in hearing performance after cochlear implantation from one patient to another, whether in silence or in noise.

Several factors influencing the results of the implant have been identified. Some of them are linked to the patient: etiology of the deafness, duration of auditory deprivation, age at implantation, residual hearing, pre- or post-lingual status of the deafness, some others are related to implant surgery (insertion of the electrode in the tympanic ramp, complete insertion, presence of a translocation, depth of electrode insertion).

Finally, there are factors related to the quality of the settings of the implant and to the brain plasticity of the patients.The 4 main factors seem to be the duration of the deafness, the age of onset of the deafness, its etiology and the duration of the patient's experience with the implant. It is assumed that the performance of cochlear implantation is strongly related to the individual's auditory processing abilities and the integrity of the central nervous system from the auditory nerve to the cortex.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patient severely to profoundly deafed according French National Authority for Health (HAS) recommendations followed in Grenoble University Hospital.

排除标准

  • cochlear malformation making impossible the cochlear implantation
  • IRM contraindications
  • Patient opposed to the use of their data in the context of the research

结局指标

主要结局

Identification of the predictive factors of hearing rehabilitation after cochlear implantation in severely to profoundly deaf adults.

时间窗: 1 year post-surgery

Correlation between a diffusion MRI biomarker extracted from preoperative brain tractography (fractional anisotropy) and the postoperative hearing performance in silence and noise after cochlear implantation.

次要结局

  • Evaluate the correlation between several predictive factors like clinical parameters, genetics ... with the MRI biomarker.(3 months, 6 months and 1 year post-surgery.)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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