Clinical Trial

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

Study acronym: ICORTHO
Recruiting
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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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-05-29
notable Primary completion pushed: 2028-02-02 -> 2028-04-17 2026-05-29
minor Completion pushed: 2028-03-01 -> 2028-05-17 2026-05-29
Trial Details
NCT Number NCT07447427
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions Severe to Profound Prelingual Hearing Loss
Enrollment 60 participants
Start Date 2026-04-17
Primary Completion 2028-04-17 (estimated)
Study Completion 2028-05-17 (estimated)
Updated on ClinicalTrials.gov 2026-05-28