Language Environment in Children With Cochlear Implants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Language Environment in Children With Cochlear Implants

Conditions
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Language Development

Intervention / Treatment
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* Behavioral: LENA and advice
* Other: LENA without advice


Participation Criteria
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Eligibility Criteria
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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 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LENA and advices<br>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 | Behavioral: LENA and advice<br>* Language recording with the LENA device, 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<br>|
| Active Comparator: LENA without advices<br>Regular speech therapy follow blindly the results of LENA | Other: LENA without advice<br>* Language recording with the LENA device. Regular speech therapy follow blindly the results of LENA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in language environment measured by LENA system |  | At the inclusion, and 5 months after the inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implant, language environment, speech therapy assessment, LENA technology