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临床试验/NCT04738968
NCT04738968进行中(未招募)不适用

Cochlear Implant for Young Children and One Deaf Ear

Universitaire Ziekenhuizen KU Leuven4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
70
试验地点
4
主要终点
Sound localization

研究概览

简要总结

Children with profound sensorineural unilateral hearing loss (UHL) lag behind in spoken language, cognition, spatial hearing, and academic performance compared to normal hearing (NH) children. Until recently children with UHL were not remediated, thereby assuming that the normal ear would provide sufficient sensory cues for speech understanding. However, this is not true. Because of the difference between the two ears they have difficulty localizing sounds and understanding speech in noise. Such auditory deprivation leads to more global changes in neurocognitive function. It is expected that a cochlear implant in the deaf ear will provide the necessary cues for hearing with two ears. The main objective of this research project is to fundamentally investigate language, cognitive, and spatial/binaural hearing longitudinally in children with unilateral deafness who receive a cochlear implant and age-matched peers.

详细描述

The main objective of the research project is to fundamentally investigate spatial and binaural hearing in a group of children with a normal hearing ear (NH) and a cochlear implant (CI) longitudinally in order to understand the relationship between sensory experience and auditory cortex plasticity. This relationship is most striking during infancy when changes in sensory input can have profound effects on the functional organization of the developing cortex. Recent studies in the auditory system have revealed the remarkably adaptive nature of sensory processing and provided important insights into the way in which cortical circuits are shaped by experience and learning. The binaural system processes and integrates differences in phase (low frequencies) or intensity (high frequencies) between sounds arriving at the left and right ear and this process goes on from birth up to adulthood. It is expected that cochlear implantation will promote normal or near-normal spatial-hearing skills in children with UHL and that intervention at 2 years of age yields the best conditions for (near-) normal development of cognition, spoken language, balance, and psychopathology, outcomes which will be monitored annually too.

Fifteen NH-CI children, aged 2 or younger, will receive a cochlear implant. This device has already been provided to over 400.000 bilaterally profoundly deaf persons worldwide and is considered a standard treatment. The novelty of the present studies lies in the treatment of unilaterally deaf children with a cochlear implant. Because of the cost of this device, the Belgian government does not reimburse a CI for children with unilateral hearing impairment, which is why a study is done to demonstrate its effectiveness. The 15 devices are provided by Cochlear. While the sample size may seem small, providing the device (25.000€ a piece) and some follow-up (mapping and/or remediation) are a large investment for Cochlear Ltd. The children will act as their own control (tested with and without CI) when possible. In addition, at the start of the research project the NH-CI children will be age-matched with 15 normal hearing children (NH-NH), and with 15 children with unilateral hearing loss without a CI (NH - x). Care will be taken to control for as many other factors as possible (e.g. other disabilities, parental and socioeconomic characteristics, ..).

It is hypothesized that the children with UHL and a CI (NH-CI) will outperform children without intervention (NH-x) because of access to bilateral input, and that provision at a very young age will result in near-normal binaural processing in the following years and hence better auditory/neuro/cognitive processing and learning in general. After cochlear implantation, the children will be followed up in terms of language development, cognitive development, binaural hearing, and academic achievements.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

It is known whether the child has a cochlear implant or not

入排标准

年龄范围
1 Year 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • profoundly hearing impaired in one ear
  • normal hearing in contralateral ear

排除标准

  • 未提供

研究组 & 干预措施

Cochlear implant for single-sided deafness

Experimental

Children with single-sided deafness, cochlear implant in the deaf ear

干预措施: Cochlear implant (Device)

Control single-sided deafness

No Intervention

Children with single-sided deafness, no intervention

Control normal hearing

No Intervention

Children with normal hearing, no intervention

结局指标

主要结局

Sound localization

时间窗: Yearly from the age of 4, until study completion (average period: 3 years)

Sound localization is assessed in a 9-loudspeaker setup with 15° degrees spacing between the loudspeakers. The stimulus is a 1-second broadband telephone sound. Results are reported as the mean absolute error, i.e. the average difference (in degrees) between the active loudspeaker and the child's response. Children with a CI are tested both with and without their device.

Spoken language comprehension

时间窗: Every 6 months between 2nd and 5th birthday

The Schlichting Test for Receptive Language is a language comprehension test for children aged 2 to 7 years. Results are reported as an age-referenced language comprehension quotient based on the total score.

Spoken language production (young children)

时间窗: Every 6 months between 2nd and 5th birthday

The Schlichting Test for Expressive Language is a language production test for children aged 2 to 7 years. Results are reported as age-referenced language quotients for each subtest, namely (1) expressive vocabulary, (2) morphosyntactic skills, (3) auditory memory, (4) pseudoword repetition, (5) story telling.

Spoken language production (older children)

时间窗: Yearly from the age of 5, until study completion (average period: 2 years)

The Clinical Evaluation of Language Fundamentals (CELF-4-NL) is a language test for children aged 5 to 18 years. Results are reported as age-referenced scores for some of the subtests, namely (1) word structure, (2) sentence repetition, (3) sentence production, (4) word categories, (5) phonologic awareness.

Spatial speech perception in noise

时间窗: Yearly from the age of 4, until study completion (average period: 3 years)

Speech perception in noise is measured for three spatial conditions using the LittleLINT speech material (numbers 1-10). Results are reported for each condition as the speech reception threshold, i.e. the level (in decibel signal-to-noise ratio, dB SNR) at which 50% of the speech is understood. Children with a CI are tested both with and without their device.

次要结局

  • Speech perception with the cochlear implant alone(At clinical visits after the age of 3, on average 2 times per year, until study completion (average period: 4 years))
  • Functional balance(Yearly from the age of 4, until study completion (average period: 3 years))
  • Cognitive development (young children)(Every 6 months until the age of 3.5 years)
  • Cognitive development (older children)(At 4 and 6 years of age (i.e. twice in total))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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