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Completed

NCT Number: NCT02853786

Language Environment in Children With Cochlear Implants

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.

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Key information

Conditions

Language Development

Age range

18 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LENA and advice

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 advice

Other

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

Primary outcomes

  1. Change in language environment measured by LENA system

    Time frame: At the inclusion, and 5 months after the inclusion

Secondary outcomes

  1. Change in language ability measured by the Grammatical Analysis Of Elicited Language Presentence level (GAEL-P)

    Time frame: At the inclusion, and 5 months after the inclusion

  2. Change in language ability measured by a vocabulary scale with peabody images (EVIP) (EVIP)

    Time frame: At the inclusion, and 5 months after the inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Hôpital Necker-Enfants Malades

Registry information

Official study title

Influence of Language Environment in Children With Cochlear Implants

Acronym: ISLODA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2016
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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