Actively Recruiting

Age: 11Months - 21Months
All Genders
NCT05917496

Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-12

30

Participants Needed

1

Research Sites

93 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

URC-CIC Paris Descartes Necker Cochin

Collaborating Sponsor

AI-Summary

What this Trial Is About

The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions. The linguistic results of the implanted deaf child are dependent on the age at the implant, but also on the auditory and linguistic stimulation in the first months following the placement of the implant. Parents are the main actors in the child's language development. Professionals can rely on the LENA tool: Language ENvironment Analysis, which objectifies the language environment of the child at home in his daily environment. It is possible to obtain statistics on the number of adult words received by the child, the number of words produced by the child as well as the exposure to media and noise. On the basis of this quantitative data, the family can be supported in an attempt to optimize the conditions for receiving their child's speech. The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis (LENA) tool, in a pediatric population implanted early, i.e. before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study.

CONDITIONS

Official Title

Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation

Who Can Participate

Age: 11Months - 21Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have profound congenital deafness
  • Have been implanted between 8 months and 18 months
  • Have had a unilateral or bilateral cochlear implant for 3 months
  • Be between 11 months and 21 months old on the day of inclusion
  • Constant wearing of the implant
  • Benefit from speech therapy
  • Have a French-speaking parent
  • Information and non-opposition of holders of parental authority to participate in the study
Not Eligible

You will not qualify if you...

  • Syndromic deafness or auditory nerve aplasia
  • Micro-cochlea or partial insertion of the electrode bundle
  • CHARGE syndrome (Coloboma, Heart defect, Atresia choanae, Retarded growth and development, Genital hypoplasia, Ear anomalies/deafness)
  • Deafness with significant central involvement (cytomegalovirus, meningitis)
  • Proven major disorders that can impact language development (Autism Spectrum Disorder, mental retardation, etc.)
  • Non-daily wearing of the cochlear implant
  • Proven uncorrected visual disturbances interfering with language assessment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Necker-Enfants Malades

Paris, France, 75015

Actively Recruiting

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Research Team

C

Clara LEGENDRE, speech therapist

CONTACT

H

Hélène MOREL

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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