Influence of Language Environment in Children With Cochlear Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Change in language environment measured by LENA system
研究概览
简要总结
The Language Environment Analysis (LENA) system is a specific tool for the language environment analysis. Children aged from 18 months to 6 years old, with cochlear implants (CIs), wear an electronic device during a day and their language interactions are registered. Then the investigators can analyze with a specific software four different parameters (adult words, conversational turns, child vocalizations and media exposure) and compare them to the language ability of the children assessed by a speech therapist. With the results, the speech therapist can advise the parents how to improve the language environment to help their children with CIs for their language development. Parents are encouraged to follow these advices at home during few months (5 months +/-1 month). Then there is a new registration of the LENA device and another language assessment are performed, to see if there is any improvement. The investigators also measure the family participation.
Hypothesis : There is an influence of the language environment measured by the LENA system on language development in children with cochlear implants.
详细描述
Over 24 months the investigators will recruit 90 patients with cochlear implants (CIs) in 2 centers.
Each patient will follow during 5 months and will have three or five visits according to the arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:*
- •Inclusion criteria:
- •Congenital profound deaf children
- •aged from 18 months to 5 years old 11 months
- •with a cochlear implant at least since 6 months
- •regular following in speech therapy
排除标准
- •non-francophone parents
- •syndrome (like CHARGE syndrome) or aplasia
- •partial insertion of the electrode array
- •associated troubles (Autism Spectrum Disorders, mental retardation...)
- •visual troubles
- •irregular use of the cochlear implant (externe part)
- •absence of parental consent
研究组 & 干预措施
LENA and advices
With the LENA results, we will advise the parents how to improve the language environment to help their children with CIs for their language development
干预措施: LENA and advice (Behavioral)
LENA without advices
Regular speech therapy follow blindly the results of LENA
干预措施: LENA without advice (Other)
结局指标
主要结局
Change in language environment measured by LENA system
时间窗: At the inclusion, and 5 months after the inclusion
次要结局
- Change in language ability measured by the Grammatical Analysis Of Elicited Language Presentence level (GAEL-P)(At the inclusion, and 5 months after the inclusion)
- Change in language ability measured by a vocabulary scale with peabody images (EVIP) (EVIP)(At the inclusion, and 5 months after the inclusion)