NCT05917496 Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
| NCT ID | NCT05917496 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Profound Congenital Deafness |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-09-13 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-09-13 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Clara LEGENDRE, speech therapist
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05917496 clinical trial?
This trial is open to participants of all sexes, aged 11 Months or older, up to 21 Months, studying Profound Congenital Deafness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05917496 currently recruiting?
Yes, NCT05917496 is actively recruiting participants. Contact the research team at clara.legendre@aphp.fr for enrollment information.
Where is the NCT05917496 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05917496 clinical trial?
NCT05917496 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Clara LEGENDRE, speech therapist at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 30 participants.