Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 13 Sept 2024
- Planned end
- Jul 2026
- Type of study
- Observational
- Treatments tested
- LENA tool: Language ENvironment Analysis
- Return of the analysis of the data of LENA
- Record updated
- 12 September 2025
Who can take part
- Age
- 11 months to 21 months
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Non-daily wearing of the cochlear implant
- 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)
- Proven major disorders that can impact language development (Autism Spectrum Disorder, mental retardation, etc.)
- Syndromic deafness or auditory nerve aplasia
- Micro-cochlea or partial insertion of the electrode bundle
- Deafness with significant central involvement (cytomegalovirus, meningitis)
- Proven uncorrected visual disturbances interfering with the performance of language level assessment tests
Where in France
- Hopital Necker Enfants MaladesParis, FranceContact: Clara LEGENDRE, speech therapistTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Patients
Children aged 11 months to 21 months on the day of inclusion in the study, with profound congenital deafness and having benefited from unilateral or bilateral cochlear implantation before 18 months of life inclusive, followed at Necker-Enfants Malades hospital and who receive a speech therapy.
Treatment: LENA tool: Language ENvironment Analysis and Return of the analysis of the data of LENA
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 12 September 2025