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临床试验/NCT03866850
NCT03866850终止不适用

Degenerative Consequences of Congenital Deafness

East Carolina University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
34
试验地点
1
主要终点
Slope of the strength duration function

研究概览

简要总结

In this study, the investigators will study one of the basic biophysical properties of the auditory nerve, charge integration, behaviorally (detection threshold versus phase duration functions). The investigators will compare charge integration in two subject groups: congenitally deafened and deafened at a later age in life. The investigators will then examine if behaviorally estimated neural excitation patterns differ between short phase duration and long phase duration stimulation. Lastly, The investigators will measure if speech recognition improves with using long phase duration stimulation, relative to using the standard default short phase duration stimulation. The primary endpoint of the study is speech recognition, and the secondary endpoints are the steepness of the detection threshold versus phase duration functions, and the width of psychophysically estimated neural excitation.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cochlear Nucleus cochlear implant users or Advanced Bionics cochlear implant users
  • Native speakers of English
  • Early onset of deafness (< 3 years of age); no requirement for age at implantation
  • Late onset of deafness (> 3 years of age); matched in duration of deafness to the early onset group
  • Has had device experience for at least one year
  • Can be child or adult at the time of enrollment

排除标准

  • 未提供

结局指标

主要结局

Slope of the strength duration function

时间窗: starting 6 months post award notice and will take up to 4 years to complete

Subjects will be measured for detection thresholds as a function of phase duration of the pulse train and the slope of the function will be derived.

次要结局

  • Psychophysically estimated neural excitation width(starting 6 months post award notice and will take up to 4 years to complete)
  • Speech recognition using long phase duration(starting 6 months post award notice and will take up to 4 years to complete)

研究者

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

Heather Wright

Professor

East Carolina University

研究点 (1)

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