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Language Environment in Children With Cochlear Implants

NCT ID: NCT02853786

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-21

Study Completion Date

2020-09-02

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.

Conditions

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Language Development

Keywords

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cochlear implant language environment speech therapy assessment LENA technology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

LENA and advice

Intervention Type BEHAVIORAL

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

LENA without advices

Regular speech therapy follow blindly the results of LENA

Group Type ACTIVE_COMPARATOR

LENA without advice

Intervention Type OTHER

Language recording with the LENA device. Regular speech therapy follow blindly the results of LENA

Interventions

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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

Intervention Type BEHAVIORAL

LENA without advice

Language recording with the LENA device. Regular speech therapy follow blindly the results of LENA

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Necker-Enfants Malades

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2016-A00155-46

Identifier Type: OTHER

Identifier Source: secondary_id

9678

Identifier Type: -

Identifier Source: org_study_id