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临床试验/NCT04043910
NCT04043910已完成不适用

Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization in Unilateral Deaf Children

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年4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
已完成
入组人数
50
试验地点
2
主要终点
Oxyhemoglobin rates

研究概览

简要总结

This study aims to compare the auditory cortical activity in response to monaural and binaural stimuli, measured by functional Near-Infrared Spectroscopy (fNIRS) between Single-sided Deaf (SSD) Children, and Normal-Hearing (NH) children from 5 to 16 years. Binaural audiological performance, speech skills and quality of life (QoL) will be compared between the 2 groups and links to with the cortical activity will be assessed.

详细描述

Binaural hearing allows strengthening of speech intelligibility in noise and sound localization. It is well known that single-sided (SSD) and bilateral asymmetric deafness lead to socio-behavioral consequences and, in children, inducing impairments in learning acquisitions.

In adults, SSD is associated with a reduction of inter-hemispheric functional asymmetry of auditory cortex on functional Magnetic Resonance Imaging. Moreover, in children with bilateral profound deafness who got one cochlear implant (inducing a form of asymmetric hearing), these clinical and functional anomalies cannot be overcome in case of a late (>1,5year) secondary implantation. This shows that once the loss of asymmetry is installed, it is difficult to recover from it.

No data about SSD in children and its cortical representation exists. In this study, the investigators hypothesized that SSD modifies the auditory cortical activation profile, linked with a deterioration of the binaural auditory skills, the global development and the quality of life If this hypothesis is confirmed, systematic and individualized rehabilitation will be needed to reduce patient's handicap and to prevent long term consequences.

The investigators will then measure the auditory cortical activity using fNIRS in 5 to 16 year-old SSD and NH children. The fNIRS system will use a sensor-bearing cap, measuring cortical activity through the scalp. Binaural hearing (speech in noise and localisation), speech assessments (global and speech development), and QoL will also be measured.

Children will undergo 2 sessions of 1 to 2 hours tests, each spaced up to 3 months apart. As they are children regularly seen in our ear-nose-throat department, a once-a-year follow-up will be proposed, on the child and his family convenience. As it is a non-interventional study, no follow-up would be needed.

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
5 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • For both groups:
  • 5 to 16 year-old children,
  • Absence of pregnancy
  • Affiliation to Social Security, and children and their parents signed consents will be necessary.
  • Participation agreement of the protocol and signature of the consent form by the person having parental authority and the child
  • For Single-sided Deafness subjects:
  • - shall present with moderate to profound unilateral hearing loss, with a hearing loss of 40 decibel(minimal thresholds), assessed on tonal, vocal audiometry, Auditory Brainstem Responses,
  • For Normal hearing subjects:
  • - shall have normal hearing, demonstrated by air thresholds below 20 decibel by an audiometric control before inclusion , matched in gender and age to children in the experimental group

排除标准

  • For both groups:
  • Antecedents of Psycho-neurological diseases,
  • Other sensorineural or motor deficiency,
  • Familial bilingualism,
  • Medications affecting vigilance.
  • pregnancy or breastfeeding

研究组 & 干预措施

Single-sided deaf group

Experimental

30 children will be included in this group

干预措施: fNIRS (Device)

Single-sided deaf group

Experimental

30 children will be included in this group

干预措施: Speech intelligibility (Other)

Single-sided deaf group

Experimental

30 children will be included in this group

干预措施: Sound localisation (Other)

Single-sided deaf group

Experimental

30 children will be included in this group

干预措施: Speech assessments (Other)

Single-sided deaf group

Experimental

30 children will be included in this group

干预措施: Quality of Life (Other)

Normal hearing group

Active Comparator

30 children will be included in this group

干预措施: fNIRS (Device)

Normal hearing group

Active Comparator

30 children will be included in this group

干预措施: Speech intelligibility (Other)

Normal hearing group

Active Comparator

30 children will be included in this group

干预措施: Sound localisation (Other)

Normal hearing group

Active Comparator

30 children will be included in this group

干预措施: Speech assessments (Other)

Normal hearing group

Active Comparator

30 children will be included in this group

干预措施: Quality of Life (Other)

结局指标

主要结局

Oxyhemoglobin rates

时间窗: 3 months

Oxyhemoglobin (O2Hb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.

Deoxyhemoglobin rates

时间窗: 3 months

Deoxyhemoglobin (HHb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.

次要结局

  • Binaural audiological performances(3 months)
  • Speech assessment(3 months)
  • Activity levels(3 months)
  • Quality of life scores(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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