Analyzing Parental Support for Children with Cochlear Implants
Official title: Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
Run by Assistance Publique - Hôpitaux de Paris · NCT05917496 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 11 Months to 21 Months |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | September 13, 2024 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT05917496 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with syndromic deafness, significant central involvement, or other major disorders affecting language development may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Long-term outcomes of MED-EL SONATA 2 Cochlear Implants in real life
This study looks at long-term results from people who received a SONATA 2 cochlear implant to see how well it works in everyday life.
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New software to help guide electrode insertion during cochlear implant surgery
A new software tool called OTOGUIDE is being tested to see if it can help surgeons place cochlear implant electrodes more accurately during surgery.
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Long-term hearing and speech outcomes after cochlear implants
This project will see if cochlear implants improve hearing, speech understanding, and quality of life in Mandarin-speaking patients of all ages before and after surgery.
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Perceptual adaptation after cochlear implantation
This trial will try different frequency maps in adults who just received a cochlear implant in one ear to see which map improves sound quality, device use, and speech understanding.
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Robotic versus manual cochlear implant electrode insertion to reduce inner-ear trauma.
This test tries a robotic insertion tool versus the usual manual technique to see if it reduces inner-ear damage and preserves residual hearing in people getting cochlear implants.
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Using robotics and electrocochleography for cochlear implant surgery
This study is testing if using a robotic system during cochlear implant surgery can help improve outcomes for people with hearing loss.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.