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NCT07447427: ICORTHO

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

Not yet recruiting Last updated 3 March 2026
What this trial tests

trial testing Speech-language therapy (observed standard care) in Severe to Profound Prelingual Hearing Loss in 60 participants. Not yet recruiting.

Timeline
15 February 2026
Primary endpoint
2 February 2028
1 March 2028

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment60
Start date15 February 2026
Primary completion2 February 2028
Estimated completion1 March 2028
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 32 Months to 48 Months, any sex, with Severe to Profound Prelingual Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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