RecruitingNot Applicable

Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation

France30 participantsStarted 2024-09-13

Plain-language 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.

Who can participate

Age range

11 Months – 21 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of conversation turns

Timeframe: 6 months

Receptive lexical level

Timeframe: 6 months

Correlation between the number of conversation turns parameter and the receptive lexical level

Timeframe: 6 months

Trial details

NCT IDNCT05917496

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07

Contact for this trial

Clara LEGENDRE, speech therapist

1 71 39 67 96 clara.legendre@aphp.fr

View on ClinicalTrials.gov More Profound Congenital Deafness trials

Plain-language summary

Who can participate

Age range

11 Months – 21 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.