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CompletedNCT02853786ISLODAUpdated Nov 18, 2020

Language Environment in Children With Cochlear Implants

An interventional study of LENA and advice and LENA without advice in Language Development, sponsored by University Hospital, Montpellier. Completed. Open to participants aged 18 Months to 6 Years. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Months to 6 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Language Development

Keywords

  • cochlear implant
  • language environment
  • speech therapy assessment
  • LENA technology
03

In context

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility Criteria:*

Inclusion 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    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

    Behavioral: LENA and advice

  • Active comparator
    LENA without advices

    Regular speech therapy follow blindly the results of LENA

    Other: LENA without advice

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02853786
Lead sponsor
University Hospital, Montpellier
Collaborators
Hôpital Necker-Enfants Malades
Responsible party
Sponsor
First posted
Aug 3, 2016
Start date
Oct 21, 2016
Primary completion
Sep 2, 2020
Completion
Sep 2, 2020
Last update
Nov 18, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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