Clinical trial NCT05917496: Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
Official title: Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Profound Congenital Deafness
Cochlear Implantation
Keywords: Profound congenital deafness
Early cochlear implantation
Language environment
Child's language development
Speech therapy assessment
Language ENvironment Analysis (LENA) tool
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 24 months with profound congenital deafness and having benefited from unilateral or bilateral cochlear implantation before 18 months of life inclusive, followed at Hôpital Necker-Enfants Maladies and who receive a speech therapy.

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.

Detailed description: 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 daily environment. On the basis of this quantitative data provided by the LENA, 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.

The LENA tool was validated in French version in 2015. It is a system of recording and automatic analysis of the language environment of the child using a box worn for 10-16 hours, with a minimum of 10 consecutive hours. For the study, the families make 2 separate recordings of 6 months at home (T1 and T2) then, a centralized analysis of all the data is carried out by the speech therapist using adapted software, 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 after T1 and after T2.

The parameters resulting from this analysis relate to four domains: "adult words", "conversation turns", "child vocalizations" and "exposure to electronic media". Average numerical scores expressed in percentiles are published at the end of the analysis. Individual scores are then compared to a standard expressed as percentiles. The content of the conversations will not be listened to and only numerical scores will be used for each of the parameters studied and obtained by computer analysis.

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

Primary outcomes:
measure: Number of conversation turns
timeFrame: 6 months
measure: Receptive lexical level
timeFrame: 6 months
measure: Correlation between the number of conversation turns parameter and the receptive lexical level
timeFrame: 6 months
Secondary outcomes:
measure: Link between 3 language environment parameters: adult words, child vocalization, exposure to electronic media and the receptive lexical level
timeFrame: 6 months
measure: Acceptability of the use of the LENA tool for children under 3 years
timeFrame: 24 months
measure: Protocolizing the individual strategies given to help and support parents to enrich their child's language environment
timeFrame: 6 months
measure: Family participation during speech therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Clara LEGENDRE, speech therapist
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Natalie LOUNDON, MD, PhD
role: STUDY_DIRECTOR
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