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临床试验/NCT03352154
NCT03352154Unknown不适用

Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants

University of Sao Paulo0 个研究点目标入组 21 人开始时间: 2016年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
21
主要终点
Improvement of the P300 Responses after CI

研究概览

简要总结

Bilateral severe to profound hearing loss is a socially disabling handicap. Cochlear implants can be used to improve hearing in cases where conventional hearing aids are not effective. There are few studies about the long latency Auditory Evoked Potential (P300), in individuals with hearing loss and Cochlear Implant (CI) users. The aim of this project is to study the behavior of P300 in users of unilateral CI.

详细描述

Bilateral severe to profound hearing loss is a socially disabling handicap. Cochlear implants can be used to improve hearing in cases where conventional hearing aids are not effective. There are few studies about the long latency Auditory Evoked Potential (P300), in individuals with hearing loss and Cochlear Implant (CI) users. The aim of this project is to study the behavior of P300 in users of unilateral CI. Twenty patients with bilateral severe and/or profound post-lingual deafness, all submitted to CI surgery, will be evaluated. Patients will be evaluated through P300 testing on the day before CI surgery, on the day of device activation and 6 months after device use. It is hoped that this study can contribute to the understanding of the mechanisms of brain plasticity involved in the recovery of hearing function after CI surgery. There are few studies on the behavior of P300 in CI users and there are no studies showing how central stimulation occurs after device implantation, during the phases of pre CI, CI activation and 6 months after CI.

研究设计

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

盲法说明

Not Apply

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with post-lingual hearing loss undergoing cochlear implant surgery

排除标准

  • •Prelingual hearing loss

研究组 & 干预措施

patients with unilateral cochlear implants submitted to P300

Experimental

Patients with unilateral cochlear implants, using the speech processor at least 6 months, submitted to P300 exam before CI surgery, on speech processor activation and after 06 months.

干预措施: P300 - Auditory long latency potential (Diagnostic Test)

结局指标

主要结局

Improvement of the P300 Responses after CI

时间窗: 06 months after CI

Improving the cognitive process on CI receivers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miguel Angelo Hyppolito

Head of Otolaryngology

University of Sao Paulo

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