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Recruiting Observational

Language Development in Children With Cochlear Implants and Speech-language Therapy Interventions

NCT07447427 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-04-17
Last updated
2026-05-28

Condition(s) studied

Severe to Profound Prelingual Hearing Loss

Investigational drug(s) / intervention(s)

Speech-language therapy (observed standard care)

Speech-language therapy (observed standard care): This observational study describes current speech-language therapy practices provided to cochlear-implanted children in routine care in France. Speech-language therapy modalities (type of approach, session frequency, and parental involvement) are observed retrospectively or prospectively to analyze their association with language development outcomes.

Study summary

Cochlear implantation is currently offered to children with severe to profound prelingual hearing loss for whom hearing aids alone are insufficient to provide access to oral language (HAS, 2009). Speech-language therapy should be implemented concurrently to support the development of oral language (HAS, 2006). Several speech therapy approaches can be proposed. The auditory-phonological (AP) approach, recommended by HAS (HAS, 2006), is a child-centered rehabilitation method that relies on visual aids such as Cued Speech or French Sign Language (LSF) to supplement the auditory information transmitted by cochlear implants.

Auditory-Verbal Therapy (AVT), widely developed in some countries, remains innovative in France. This therapy is more parent-centered, aiming to teach caregivers how to model language to optimally stimulate their child's language development. It excludes the use of visual aids such as Cued Speech or LSF and relies solely on auditory stimulation provided by cochlear implants. When implemented, AVT should be initiated as early as possible to achieve the best language outcomes.

The frequency of speech therapy sessions following implantation is also not standardized. Various international recommendations emphasize early, regular, and family-centered intervention. However, high-level evidence on the relationship between session frequency and language development is limited.

A similar observation applies to parental involvement. Although it is recognized as essential for language development in implanted children's speech therapy, few studies provide a consensus on how to implement parental involvement during therapy sessions.

Eligibility

Sex
ALL
Min age
32 Months
Max age
48 Months
Healthy volunteers
No
Inclusion Criteria: * Children with severe to profound prelingual hearing loss * Implanted between 8 and 24 months of age * At least 24 months of follow-up after implantation * No parental objection from legal guardians Exclusion Criteria: * Children with progressive hearing loss * Severe neurological pathology, identified by MRI and/or neuro-pediatric assessment * Suspected or diagnosed Autism Spectrum Disorder (ASD)

Primary outcome measure(s)

  • To observe the effect of speech-language therapy modalities on morphosyntactic comprehension in implanted children. — 24 months after cochlear implantation
    Morphosyntactic comprehension will be assessed using the standardized EVALO 2-6 test. The subtest involves orally presenting sentences to the child, who must manipulate Playmobil® figures according to the sentence heard. The outcome corresponds to the score obtained on this subtest.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Necker - Enfants Malades - Service d'ORL et chirurgie cervico-faciale Paris Île-de-France Region Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07447427 on ClinicalTrials.gov ↗ ← All trials in France