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Language Environment in Children With Cochlear Implants

Influence of Language Environment in Children With Cochlear Implants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02853786
Acronym
ISLODA
Enrollment
90
Registered
2016-08-03
Start date
2016-10-21
Completion date
2020-09-02
Last updated
2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Language Development

Keywords

cochlear implant, language environment, speech therapy assessment, LENA technology

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.

Interventions

BEHAVIORALLENA 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

OTHERLENA without advice

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

Sponsors

Hôpital Necker-Enfants Malades
CollaboratorOTHER
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Months to 6 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in language environment measured by LENA systemAt the inclusion, and 5 months after the inclusion

Secondary

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026