Language Environment in Children With Cochlear Implants

Not Applicable

Completed

• Conditions: Language Development
• Interventions: Behavioral: LENA and advice; Other: LENA without advice

• Registration Number: NCT02853786
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Study Start: 2016-10-21
• Primary Completion: 2020-09-02
• Study Completion: 2020-09-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LENA and advices	LENA and advice	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
LENA without advices	LENA without advice	Regular speech therapy follow blindly the results of LENA

Primary Outcome Measures

Name	Time	Method
Change in language environment measured by LENA system	At the inclusion, and 5 months after the inclusion

Secondary Outcome Measures

Name	Time	Method
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