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2023年10月17日

概览

阶段
不适用
干预措施
ABFnoS then ABFS (Cochlear implant)
疾病 / 适应症
Sensorineural Hearing Loss, Bilateral
发起方
MED-EL Elektromedizinische Geräte GesmbH
入组人数
20
试验地点
1
主要终点
Accuracy of sound localization
状态
招募中
最后更新
3个月前

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. This variability could be due to different processing times between CI and contralateral HA. Recently, MED-EL (Austria) has developed a new approach to synchronize the treatment time of the CI with that of the contralateral HA via the fitting software. This new approach takes into account the different treatment times between CI and contralateral HA and allows synchronization between the 2 systems (CI and HA). This strategy (ABFS) could therefore allow a better integration of information in bimodal hearing and in particular improve the sound localization compare to a strategy without synchronization (ABFnoS). 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. Plan of the study: It is a prospective open monocentric randomized crossover study: Measures will be done on the patient at 6 weeks and 12 weeks post-activation.

注册库
clinicaltrials.gov
开始日期
2023年10月17日
结束日期
2026年12月15日
最后更新
3个月前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

发起方
MED-EL Elektromedizinische Geräte GesmbH
责任方
Sponsor

入排标准

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

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

干预措施: ABFnoS then ABFS (Cochlear implant)

ABFS then ABFnoS

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

干预措施: ABFS then ABFnoS (Cochlear implant)

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)

研究点 (1)

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