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NCT02853786 Clinical Trial

Language Environment in Children With Cochlear Implants

Language Development Clinical Trial

— ISLODA  

Official title:
Influence of Language Environment in Children With Cochlear Implants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02853786
Other study ID # 9678
Secondary ID 2016-A00155-46
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2016
Est. completion date September 2, 2020

Study information
Verified date November 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date September 2, 2020
Est. primary completion date September 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Months to 6 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• LENA and advice
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
Other:
• LENA without advice
Language recording with the LENA device. Regular speech therapy follow blindly the results of LENA

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Montpellier Hôpital Necker-Enfants Malades

Outcome
Type Measure Description Time frame Safety issue
Primary Change in language environment measured by LENA system At the inclusion, and 5 months after the inclusion
Secondary 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
Secondary Change in language ability measured by a vocabulary scale with peabody images (EVIP) (EVIP) At the inclusion, and 5 months after the inclusion
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