NCT02853786

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 21, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

3.9 years

First QC Date

July 7, 2016

Last Update Submit

November 16, 2020

Conditions

Language Development

Keywords

cochlear implantlanguage environmentspeech therapy assessmentLENA technology

Outcome Measures

Primary Outcomes (1)

  • Change in language environment measured by LENA system

    At the inclusion, and 5 months after the inclusion

Secondary Outcomes (2)

  • 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

Study Arms (2)

LENA and advices

EXPERIMENTAL

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

Behavioral: LENA and advice

LENA without advices

ACTIVE COMPARATOR

Regular speech therapy follow blindly the results of LENA

Other: LENA without advice

Interventions

LENA and adviceBEHAVIORAL

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 and advices
LENA without adviceOTHER

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

LENA without advices

Eligibility Criteria

Age18 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

August 3, 2016

Study Start

October 21, 2016

Primary Completion

September 2, 2020

Study Completion

September 2, 2020

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share