Analyzing Parental Support for Children with Cochlear Implants
Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
This study looks at how parents can help their young children with cochlear implants develop language skills by recording and analyzing their home conversations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 11 Months to 21 Months |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05917496 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the language development of children with profound congenital deafness who receive cochlear implants before 18 months of age. It utilizes the LENA tool, which records and analyzes the child's language environment at home, providing quantitative data on adult words heard and words produced by the child. Families will undergo two recording sessions over six months, and the data will be analyzed by speech therapists to optimize speech therapy support. The goal is to understand how parental involvement influences language outcomes in these children.
Who should consider this trial
Good fit: Ideal candidates are children aged 11 to 21 months with profound congenital deafness who have received a cochlear implant and are benefiting from speech therapy.
Not a fit: Patients with syndromic deafness, significant central involvement, or other major disorders affecting language development may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance language development strategies for children with cochlear implants, leading to improved communication skills.
How similar studies have performed: While the use of the LENA tool has been validated, this specific approach to analyzing parental support in the context of early cochlear implantation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Necker-Enfants Malades — Paris, France (Recruiting)
Study contacts
- Principal investigator: Clara LEGENDRE, speech therapist — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Clara LEGENDRE, speech therapist
- Email: clara.legendre@aphp.fr
- Phone: 1 71 39 67 96
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.