Actively Recruiting

Age: 11Months - 21Months
All Genders
ID05917496

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

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

30

Participants Needed

1

Research Sites

N/A

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

Researchers are exploring how the language environment affects the development of children with profound congenital deafness who received cochlear implants early in life. This study focuses on children implanted before 18 months and under 24 months old at the start, aiming to analyze the effect of speech therapy parental support using data from the Language ENvironment Analysis (LENA) tool. The LENA tool objectively measures the child's home language environment by recording adult words, child vocalizations, conversation turns, and exposure to electronic media. Families participate by using the LENA device, which the child wears for 10 to 16 hours on two separate occasions spaced six months apart (T1 and T2). Speech therapists analyze the recordings using specialized software and provide personalized feedback to parents after each recording period to help improve the child's language skills. The study does not listen to conversation content but uses numerical data to guide support. During the study, families make two home recordings of the child's language environment, and speech therapists review the data to assess parameters like conversation turns and receptive vocabulary. The primary outcomes include measuring conversation turns, receptive lexical level, and their correlation after six months. Secondary outcomes examine links between language environment factors and language development, acceptability of the LENA tool, parental support strategies, and family participation in therapy. The study continues until July 2026, with ongoing evaluation and support at regular intervals.

CONDITIONS

Brief 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
  • Implanted between 8 months and 18 months of age
  • Have had a unilateral or bilateral cochlear implant for at least 3 months
  • Be between 11 months and 21 months old at inclusion
  • Wear the cochlear implant constantly
  • Receive speech therapy
  • Have a French-speaking parent
  • Parental authority holders provide informed consent and do not oppose participation
Not Eligible

You will not qualify if you...

  • Syndromic deafness or auditory nerve aplasia
  • Micro-cochlea or partial electrode insertion
  • CHARGE syndrome
  • Deafness with significant central involvement (e.g., cytomegalovirus, meningitis)
  • Major disorders impacting language development (e.g., Autism Spectrum Disorder, mental retardation)
  • Non-daily use of cochlear implant
  • Uncorrected visual disturbances interfering with language assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Two periods of 6 months each

Participants wear the LENA device at home to record their child's language environment during two separate 6-month periods. The recordings capture adult words, conversation turns, child vocalizations, and exposure to electronic media.

2 recording periods at home, each lasting 6 months

Return of Analysis and Parental Support

Duration - Concurrent with the 6-month recording periods

Speech therapists analyze the LENA data and provide personalized feedback and advice to parents to support and improve their child's language development after each 6-month recording period.

2 feedback sessions with speech therapists after each recording period

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

H

Hélène MOREL

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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Published Research Related To This Trial

Best practices in family-centered early intervention for children who are deaf or hard of hearing: an international consensus statement.

Mary Pat Moeller, Gwen Carr, Leeanne Seaver...

https://pubmed.ncbi.nlm.nih.gov/24030911