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Severe to Profound Prelingual Hearing LossICORTHONCT07447427

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

An observational study of Severe to Profound Prelingual Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 32 to 48 months
How many people
60 participants
Where
1 siteFrance
Study dates
17 Apr 2026to 17 May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 32 to 48 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children followed at Necker Hospital for their hearing loss and cochlear implantation

Who may be able to join

  • 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

Who cannot join

  • Children with progressive hearing loss
  • Severe neurological pathology, identified by MRI and/or neuro-pediatric assessment
  • Suspected or diagnosed Autism Spectrum Disorder (ASD)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Hôpital Necker - Enfants Malades - Service d'ORL et chirurgie cervico-faciale

    Paris, Île-de-France Region, 75015

    Recruiting

Other trials in France

About this study

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.

Read more

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.

Read the detailed description

Hearing loss is the most common sensory disability in children worldwide. The development of hearing aids and cochlear implants now allows children to access oral language development. The latest recommendations from the French National Authority for Health (HAS, 2011) advocate for early auditory intervention as soon as hearing loss is diagnosed. In cases of severe to profound hearing loss, when hearing aids do not provide sufficient auditory access, cochlear implantation should be proposed to parents as early as possible, ideally before 12 months of age. Concurrently, speech-language therapy should be initiated to support the child's auditory and oral language development. Therapy should begin as early as the diagnosis allows, ideally within the first months of life (HAS, 2006). Various therapy approaches and modalities are currently proposed.

According to HAS recommendations (2009), two main approaches are described for rehabilitating deaf children: the visuo-gestural approach and the auditory-phonological (AP) approach. The visuo-gestural approach prioritizes gestural communication without stimulating the auditory pathway and does not necessarily amplify residual hearing. Its goal is to support the child in learning a visual language, namely French Sign Language (LSF). In contrast, the AP approach aims to develop the child's oral language by stimulating the auditory pathway early, using hearing aids or cochlear implants. In AP, spoken input to the child is complemented by visual aids such as Cued Speech (CS) or signed French (FS). While no consensus exists on the preferred use of FS or CS, recommendations support interventions with complementary gestural support, excluding spoken language alone.

A more recent method, Auditory-Verbal Therapy (AVT), has emerged, emphasizing parental involvement. AVT considers parents as primary agents in their child's language development. Trained speech therapists guide parents on how to optimally stimulate their child's hearing and language in everyday situations. The main goal is to teach parents to model their language in a way that supports precise perceptual and language objectives (Estabrooks, 2020). Unlike traditional therapy focused on the child, AVT centers on parental objectives: parental language modeling directly supports the child's language development. AVT relies exclusively on auditory stimulation, without gestural or visual supports, and requires early auditory intervention via hearing aids or cochlear implants. The method differs from AP by focusing on parental objectives and excluding visual supports. Early implementation is essential for optimal language outcomes (Salhi, 2019). While short-term therapy may not fully compensate for initial language delays (Dornan et al., 2007; Jackson et al., 2014), continuation can bring children to age-appropriate language levels after 2-3 years (Dornan et al., 2009, 2010). In France, AVT remains innovative: a recent survey showed that only 1% of professionals use AVT, while 68% use FS and 46% use CS (Van Bogaert, Loevenbruck \& Vilain, 2024). Parents who received AVT reported higher satisfaction and greater progress compared to other interventions.

Several studies have compared perceptual and language outcomes in children receiving different therapy methods. Some studies found no significant differences, suggesting that therapy type has limited impact on language development (Yanbay et al., 2014). In these studies, intergroup variability, particularly age at implantation, was a major factor influencing outcomes (Dettman et al., 2013). Other studies indicate that AVT over 2 years post-implantation improves the likelihood of age-appropriate language outcomes, making therapy type a key determinant (Percy-Smith et al., 2018). Thomas et al. (2019) reported superior perceptual and language outcomes over seven consecutive years for children receiving AVT. Early French studies suggest AVT may enhance certain language skills, while CS exposure may be equally effective for others (Van Bogaert, 2024). Overall, existing studies provide inconsistent evidence, and heterogeneity in age at implantation remains a major limitation.

In practice, the frequency of speech therapy sessions varies widely. European and American guidelines emphasize early, regular, and family-centered intervention (De Raeve et al., 2023; ACIA, 2015). In France, HAS recommends early and regular follow-up but does not specify session frequency (HAS, 2009). To date, only one study has specifically examined the number of sessions for implanted children (Mallene, 2021), and high-level evidence remains limited (De Raeve et al., 2023).

Parental involvement is recognized as a key factor in speech therapy for deaf children (De Raeve et al., 2023; ACIA, 2015). Several studies show that structured parental coaching improves both parent-child communication and the child's oral language development. However, no consensus exists regarding implementation strategies for parental involvement in therapy for implanted children (Giallini et al., 2021). No French study has yet examined the impact of parental involvement on language outcomes in implanted children.

Being tested
Speech-language therapy (observed standard care)
Keywords
Cochlear implant, Prelingual deafness, Speech-language therapy, Auditory-verbal therapy (AVT), Parental involvement
Medical subject headings
Deafness, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Speech-language therapy (observed standard care)Other

    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 groups in NCT07447427
Study groupRoleWhat they receive
Cochlear-implanted childrenChildren with severe to profound prelingual hearing loss who received a cochlear implant before the age of 2. This cohort will be assessed for speech-language therapy interventions, including method (AP or AVT), session frequency, and parental involvement, and their impact on language development outcomes.
Receives: Other: Speech-language therapy (observed standard care)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To observe the effect of speech-language therapy modalities on morphosyntactic comprehension in implanted children.

    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.

    Measured: 24 months after cochlear implantation

Secondary outcomes (8)
  1. Lexical development

    Lexical development will be assessed using the Evalo 2-6 Naming Test

    Measured: 24 months after cochlear implantation

  2. Lexical development

    Lexical development will be assessed using the Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5)

    Measured: 24 months after cochlear implantation

  3. To observe the correlation between speech-language therapy modalities and the level of parental involvement during therapy

    Parental involvement will be assessed using the Moeller Parental Involvement Scale (MP). The Moeller Parental Involvement Scale is a clinician-rated scale that assesses the degree of parental participation in their child's intervention. The scale ranges from 1 to 5. A score of 1 indicates "limited participation" and a score of 5 indicates "ideal participation". Higher scores represent a better outcome (greater parental involvement).

    Measured: 24 months after cochlear implantation

  4. To observe the correlation between speech-language therapy modalities and the level of parental involvement during therapy

    Parental involvement will be assessed using the global parental sense of competence scale (EGSCP). The EGSCP (Global Parental Sense of Competence Scale) is a self-reported questionnaire assessing parental sense of competence across five domains: discipline, care, learning, affective relationships, and play. It consists of 25 items. Each item is rated on a visual analogue scale ranging from 0 ("disagree") to 100 ("agree"). A higher score represents a better outcome (higher parental sense of competence).

    Measured: 24 months after cochlear implantation

  5. To observe the correlation between speech-language therapy modalities and the child's auditory perception abilities.

    Auditory perception will be assessed using the Boorsma word list score, Evaluation of speech recognition using the Boorsma phonetically balanced word list. The score is calculated as the percentage of words correctly identified. Scores range from 0% to 100%. A higher score indicates a better outcome (better speech perception).

    Measured: 24 months after cochlear implantation

  6. To observe the correlation between speech-language therapy modalities and the child's auditory perception abilities.

    Auditory perception will be assessed using the audiogram thresholds, implant datalogging. Hearing sensitivity measured in decibels (dB) across various frequencies.

    Measured: 24 months after cochlear implantation

  7. To observe the correlation between speech-language therapy modalities and the child's auditory perception abilities.

    Auditory perception will be assessed using the parental questionnaire (PEACH). The PEACH is a 13-item parental questionnaire designed to evaluate a child's use of hearing in everyday life. Total scores are calculated. A higher score indicates a better outcome.

    Measured: 24 months after cochlear implantation

  8. To observe the characteristics of speech-language therapy provided (type of approach, session frequency, parental involvement) and their relation to language development outcomes.

    A study-specific questionnaire designed to assess parental involvement and perception of speech-language therapy. It includes 14 items on therapy characteristics (frequency, tools, involvement) and 11 items on parental feelings.

    Measured: 24 months after cochlear implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start17 Apr 2026
  3. Primary completion17 Apr 2028 (estimated)
  4. Study completion17 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07447427
Sponsor's protocol ID
APHP251948
Other IDs
IDRCB
Acronym
ICORTHO
Status last verified
May 2026
First submitted
11 Feb 2026
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Severe to Profound Prelingual Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Iris ATTAL (01 44 49 46 87 ext. +33, iris.attal@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To observe the effect of speech-language therapy modalities on morphosyntactic comprehension in implanted children. (time frame: 24 months after cochlear implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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