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NCT07447427: ICORTHO
Language Development in Children With Cochlear Implants and Speech-language Therapy Interventions
trial testing Speech-language therapy (observed standard care) in Severe to Profound Prelingual Hearing Loss in 60 participants. Not yet recruiting.
2 February 2028
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 15 February 2026 |
| Primary completion | 2 February 2028 |
| Estimated completion | 1 March 2028 |
| Sites | 1 location across France |
Drugs / interventions tested
- Speech-language therapy (observed standard care)
Conditions studied
- Severe to Profound Prelingual Hearing Loss — all drugs for Severe to Profound Prelingual Hearing Loss →
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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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07447427 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 3 March 2026
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing