跳至主要内容
临床试验/NCT05898659
NCT05898659招募中不适用

Comparison of a Bimodal Fitting With Synchronization and a Conventional Bimodal Fitting in Newly Implanted Cochlear Patient. Prospective Monocentric Randomized Double-blind Crossover Study.

MED-EL Elektromedizinische Geräte GesmbH1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年10月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Accuracy of sound localization

研究概览

简要总结

Main objective:

For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.

Secondary objectives:

Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS for the auditory skills experienced by the subject.

详细描述

Introduction: Cochlear implantation allows the rehabilitation of profound bilateral deafness, restoring speech perception and verbal communication when the traditional hearing aid no longer provides satisfactory hearing gain.

A cochlear implant includes an electrode array and its functioning is based on the principle of cochlear tonotopy: Each electrode encodes a frequency spectrum according to its position in the cochlea (high frequencies are assigned to the basal electrodes and low frequencies to the apical electrodes). The cochlear implant thus breaks down the frequency spectrum into a number of frequency bands via bandpass filters corresponding to the number of electrodes in the implant. During the fitting these bands can be modified by the audiologist.

MED-EL has developed a fitting strategy (ABF) that allows, from a post-operative scanner, to calculate the theoretical characteristic frequency of neurons stimulated by each electrode contact and to transmit this information to the fitting software of the CI.

Bimodal hearing refers to the use of a CI in one ear with a HA on the contralateral side.

This association allows for adults and children a better perception of speech in quiet and in noise, a better perception of music, hearing comfort, better sound quality, better localization of sound and, consequently, a better quality of life compared to unilateral CI alone. However, there is great variability in the integration process; while some bimodal users show substantial benefits, others receive little or no benefit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

盲法说明

Double blind study: The patient and the investigator don't know the fitting.

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

  • Adult patient (>= 18 years old) speaking French
  • Patient who fulfils the criteria for cochlear implantation
  • Total hearing loss for less than 5 years

排除标准

  • retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
  • patient with residual hearing < 70 dB hearing level (HL) at 250 Hz and 500 Hz and < 80 dB HL at 1000 Hz on the contralateral ear

研究组 & 干预措施

ABFnoS then ABFS

Active Comparator

Cochlear Implant with ABFnoS first during 6 weeks then with ABFS during 6 weeks

干预措施: ABFnoS then ABFS (Cochlear implant) (Device)

ABFS then ABFnoS

Active Comparator

Cochlear Implant with ABFS first during 6 weeks then with ABFnoS during 6 weeks

干预措施: ABFS then ABFnoS (Cochlear implant) (Device)

结局指标

主要结局

Accuracy of sound localization

时间窗: at 12 weeks post-activation

The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.

Accuracy of sound localization

时间窗: at 6 weeks post-activation

The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.

次要结局

  • Speech recognition in noise(at 12 weeks post-activation)
  • Auditory skills experienced by the patient(at 12 weeks post-activation)
  • Bias of sound localization(at 12 weeks post-activation)
  • Bias of sound localization(at 6 weeks post-activation)
  • Speech recognition in noise(at 6 weeks post-activation)
  • Auditory skills experienced by the patient(at 6 weeks post-activation)

研究者

发起方
MED-EL Elektromedizinische Geräte GesmbH
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验