Ireland
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Recruiting Observational

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

NCT05917496 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-09-13
Last updated
2025-09-12

Condition(s) studied

Profound Congenital DeafnessCochlear Implantation

Investigational drug(s) / intervention(s)

LENA tool: Language ENvironment AnalysisReturn of the analysis of the data of LENA

LENA tool: Language ENvironment Analysis: Recording of the language environment of the child at home, in daily environment, with the LENA. The parameters recorded relate to four domains: "adult words", "conversation turns", "child vocalizations" and "exposure to electronic media". The LENA box is worn for 10-16 hours, with a minimum of 10 consecutive hours. the families make 2 separate recordings of 6 months at T1 and T2.

Return of the analysis of the data of LENA: The analysis of the LENA data is carried out by the speech therapist using the LENA Pro Version Software v3.4, during the times T1 and T2. The return of the analysis of the data collected via the LENA will be made to the family of the patient after T1 and after T2 and personalized advice will then be given to parents with the aim of improving their child's language skills.

Study summary

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.

Eligibility

Sex
ALL
Min age
11 Months
Max age
21 Months
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Syndromic deafness or auditory nerve aplasia * Micro-cochlea or partial insertion of the electrode bundle * CHARGE syndrome (acronym for Coloboma, Heart defect, Atresia choanae, Retarded growth and development, Genital hypoplasia, Ear anomalies/deafness or in French coloboma, cardiac malformation, choanal atresia, growth retardation and/or mental retardation, genital hypoplasia, ear abnormalities/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 the performance of language level assessment tests

Primary outcome measure(s)

  • Number of conversation turns — 6 months
    Comparison of the variation in language environment for the number of conversation turns recorded at T1 and the number of conversation turns recorded at T2 after speech therapy support offered at T1 and based on data provided by the Language ENvironment Analysis (LENA) tool. Average numerical scores expressed in percentiles are produced at the end of the analysis. The individual scores are then compared with a standard expressed in percentiles.
  • Receptive lexical level — 6 months
    Receptive lexical level measured by the speech therapy test (IFDC, French inventories of Communicative Development) at T1 and T2. Each child's individual result is given in percentiles according to chronological age. It is based on an evaluation sheet with benchmarks in percentiles (10th to 90th) or percentages.
  • Correlation between the number of conversation turns parameter and the receptive lexical level — 6 months
    The correlation between the "conversation turns" parameter recorded at T1 and T2 and the receptive lexical level measured by the speech therapy test (IFDC, French inventories of Communicative Development) at T1 and T2 will be carried out.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Necker-Enfants Malades Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05917496 on ClinicalTrials.gov ↗ ← All trials in France