跳至主要内容
临床试验/NCT02748915
NCT02748915已完成不适用

Estimation of Perceptual Levels Used in Cochlear Implant Fitting Based on Electrophysiological Measures

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2016年1月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
ECAP threshold

研究概览

简要总结

The primary objective of this research is to evaluate the relationships between multiple data from cochlear implant (CI) adult users to and to estimate predictive models of their fitting parameters. In a group of patients, the Electrically-evoked Compound Action Potentials (ECAP) will be collected intra-operatively and the correlation with demographic data (deafness duration, age deafness onset, etiology, duration of cochlear implant use of CI), auditory performances and subjective measures used for implant fitting (hearing threshold and most comfortable level) will be calculated. In a second group of experienced users (more than 9months of use of their CI), ECAP and Electrically-evoked Auditory Brainstem Response (EABR) will be collected after 9 months of CI experience and after 12 months or more of use. Correlation analyzes with demographic data, performance and fitting parameters will be performed as well. Statistical predictive models for both fitting at the activation or in experienced users should be developed according to the correlation analysis.

The secondary objective is to evaluate the effects of simultaneous stimulation on hearing performances. Simultaneous stimulations will be delivered in one ear (bimodal condition) in patients using an Electro-Acoustic Stimulation device (EAS) or in the two ears (binaural condition) for bilateral CI users. ECAP, EABR and speech perception will be measured and compared in the different conditions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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
否

入选标准

  • •Good general health status including no neuropsychological diseases affecting intellectual capacities
  • •Users of cochlear implant or electro-acoustic stimulation devices
  • •Normal otoscopy
  • •No excessive sound exposure within 48h before the measure

排除标准

  • •For women, possibility of pregnancy (absence of effective contraception or confirmed menopause);
  • •Concomitant use of ototoxic or psychotropic treatment with anxiolytic and / or antipsychotic

研究组 & 干预措施

Patients using cochlear implants

Experimental

All patients using cochlear implants included in the study will take electrophysiological and psychoacoustic tests to measure auditive parameters regarding the study objectives : ECAP, EABR, speech recognition and MCL.

干预措施: Electrophysiological and psychoacoustic tests (Other)

Patients using EAS device

Experimental

Patients using EAS device for more than 11 months will take electrophysiological and psychoacoustic tests with the implant functioning only with electrical pulses or in bimodal mode to measure ECAP, EABR, speech recognition and MCL ; this will allow to perform bimodal comparison.

干预措施: Electrophysiological and psychoacoustic tests (Other)

Patients with bilateral cochlear implant

Experimental

Patients with bilateral cochlear implant for more than 11 months will take electrophysiological and psychoacoustic tests to measure ECAP, EABR, speech recognition, and MCL. The binaural interaction component will also be measured ; this will allow to perform binaural comparison.

干预措施: Electrophysiological and psychoacoustic tests (Other)

结局指标

主要结局

ECAP threshold

时间窗: from 11 months after cochlear implant activation

ECAP amplitude growth function (AGF) will be recorded on three cochlear sites (basal, medial, apical) in all patients using their implants for more than 11 months. ECAP thresholds (in current unit) will be determined, compared according to the stimulation sites and correlation tests with the other measures will be performed. These records could also be compared to ECAP AGF recorded in clinical routine/during control visit before these 11 months that includes intra-operative records when available. The ECAP threshold recorded with and without acoustic stimulations will be compared in patients using EAS devices.

次要结局

  • ECAP AGF slope(9 months after cochlear implant activation)
  • EABR wave V maximal amplitude(9 months after cochlear implant activation)
  • ECAP maximal amplitude(9 months after cochlear implant activation)
  • ECAP latency(9 months after cochlear implant activation)
  • EABR wave V threshold(9 months after cochlear implant activation)
  • EABR binaural interaction component (BIC)(from 11 months after cochlear implant activation)
  • Speech recognition score(9 months after implant cochlear implant activation)
  • ECAP threshold(9 months after cochlear implant activation)
  • EABR wave V latency(9 months after cochlear implant activation)
  • EABR wave V AGF slope(9 months after cochlear implant activation)
  • Most Comfort Level (MCL)(9 months after implant cochlear implant activation)
  • ECAP maximal amplitude(from 11 months after cochlear implant activation)
  • ECAP latency(from 11 months after cochlear implant activation)
  • ECAP AGF slope(from 11 months after cochlear implant activation)
  • EABR wave V maximal amplitude(from 11 months after cochlear implant activation)
  • EABR wave V latency(from 11 months after cochlear implant activation)
  • EABR wave V threshold(from 11 months after cochlear implant activation)
  • EABR wave V AGF slope(from 11 months after cochlear implant activation)
  • Most Comfort Level (MCL)(from 11 months after cochlear implant activation)
  • Speech recognition score(from 11 months after implant cochlear implant activation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验