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临床试验/NCT05275712
NCT05275712Unknown不适用

Outcome of Cochlear Implant in Children at Assiut University Hospital

Assiut University0 个研究点目标入组 150 人开始时间: 2023年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
Speech perception test with figures

研究概览

简要总结

Evaluation of the outcome of cochlear implanted children at audiovestibular medicine unit in Assiut university hospital.

详细描述

Hearing loss is one of the most common health problems affecting people around the world with an average international incidence of 5% .

In Egypt, it affects 16% of the population with an incidence of 14% in children less than 14 years old. 86% of deaf patients had conductive hearing loss (CHL), while sensorineural hearing loss (SNHL) was found in 14%, with a male to female ratio of 3:2 HL .

Cochlear implantation (CI) has become a routine procedure in the United States and worldwide for the management of severe-to-profound SNHL loss. It is a remarkable example of success that was made possible through collaboration between engineers, surgeons, scientists and the medical community .

Early cochlear implantation had a long-term positive impact on auditory and verbal development, if auditory stimulation does not occur within this timeframe, the auditory system degenerates. It has been suggested that in the absence of normal auditory stimulation there is a period of about 3.5 years during which the central auditory system retains its maximum plasticity. This can extend in some children up to the age of approximately 7 years, after which it is significantly reduced. The earlier implantation causes better outcomes, including improved language development, speech perception and speech production skills .

Early research reviews found that the ability to communicate in spoken language was better the earlier the implantation was performed. These reviews also found that cochlear implants provide open set speech understanding for the majority of implanted profoundly hearing-impaired children, and that it was not possible to accurately predict the specific outcome of the given implanted child .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
4 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between (4-14 years) who underwent cochlear implantation surgery between 2015 and
  • Both sexes will be included.

排除标准

  • Patients with irregular device use.
  • Implantation less than 6 months.
  • Patients who refused to participate in the study.

结局指标

主要结局

Speech perception test with figures

时间窗: 2 years

Parents' perspective Questionnaire

时间窗: 2 years

The outcome of CI surgery on Quality of Life (QoL) has been greatly investigated via parental questionnaire assessment. This questionnaire was designed with 11 subscales and 58 questions in total. All questions were scaled from 1 to 5: (1 strongly agree; 2 agree; 3 neither agree nor disagree; 4 disagree; and 5 strongly disagree)

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

Sally Shenouda Bolis

Resident doctor

Assiut University

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