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临床试验/NCT07447427
NCT07447427招募中不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
To observe the effect of speech-language therapy modalities on morphosyntactic comprehension in implanted children.

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
32 Months 至 48 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Cochlear-implanted children

Children 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.

干预措施: Speech-language therapy (observed standard care) (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Lexical development(24 months after cochlear implantation)
  • To observe the correlation between speech-language therapy modalities and the level of parental involvement during therapy(24 months after cochlear implantation)
  • To observe the correlation between speech-language therapy modalities and the child's auditory perception abilities.(24 months after cochlear implantation)
  • To observe the characteristics of speech-language therapy provided (type of approach, session frequency, parental involvement) and their relation to language development outcomes.(24 months after cochlear implantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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