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Development of a Deaf Child With a Cochlear Implant. (DECCODES)

T

Toulouse University Hospital

Status

Completed

Conditions

Deafness

Treatments

Behavioral: Free hearing test categorization
Behavioral: NEPSY (two domains: "memory and learning" and "attention and executive functions").
Behavioral: Early Social Communication Scale (ECSP)
Behavioral: psychomotor infancy development scale
Behavioral: Evaluation of the detection of non-linguistic sounds

Study type

Observational

Funder types

Other

Identifiers

NCT02539901
11 227 02
2011-A01058-33 (Registry Identifier)

Details and patient eligibility

About

Cochlear implantation enables profoundly deaf children to acquire speech and develop their understanding of spoken language. However, there are significant interindividual differences in the results obtained with the implant. Given the lack of theoretical knowledge on acoustic predictors, cognitive and language to obtain optimum speech recognition with cochlear implants associated with a good communicative and language development of deaf children, the investigators intend to achieve a preliminary longitudinal study aimed to describe the cognitive, communicative and perceptive implanted deaf children.

The main objective of our study is to describe the cognitive and communicative development of deaf children implanted from the pre-implant assessment to 18 months post-implantation, by addressing the following aspects:

  • The psychomotor and cognitive development assessed using the Brunet-Lézine test;
  • The development of preverbal communication, evaluated using the Early Social Communication Scale.

Enrollment

73 patients

Sex

All

Ages

12 months to 9 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

To achieve this study, two cohorts will be formed:

  • A cohort of deaf children aged 12 to 30 months:

    • Be reached a bilateral profound sensorineural hearing loss (greater than 90 dB hearing loss, as classified by the International Bureau for Audiophonology, 1997);
    • Raise a cochlear implant;
    • Being affiliated to a social security scheme.
    • Consent representatives of parental authority (or at least one of the two)
  • A cohort of deaf children from 6 to 9 years:

    • Be reached a bilateral profound sensorineural hearing loss;
    • Be holder of a cochlear implant for at least 3 years;
    • Consent representatives of parental authority (or at least one of the two).
  • A group of normal hearing typically developing children:

this group will provide benchmarks for perception tests. It consists of two sub-groups:

  • Children with normal hearing typically developing 12 to 30 months; children whith a general, linguistic and normal psychomotor evaluated on the basis of prior clinical examination at baseline and on the compilation of their health record. They must not present psychomotor retardation or language.

  • Children with normal hearing in typical development 6 to 9 years.

    • Be matched in age and sex with deaf children (a pairing with a child on the criteria defined above). In terms of developmental age, we can consider as having comparable in terms of age development of children with:
    • +/- 6 months for the population of children 6 to 9 years
    • +/- 1 month for the population of children 12 to 30 months.
    • Have a typical development, evaluated by a grade level for their age;
    • Consent representatives of parental authority (or at least one of the two).

Exclusion criteria

Will be excluded from our study subjects where there is an inability to meet the tests, either in situations:

  • Impossible to understand instructions
  • Blindness
  • Impossible to meet the tests
  • Multihandicap
  • A legal impossibility. Furthermore, children will be excluded for which there is a refusal on the part of the parents or of the child to participate in the study (for children old enough to express their opinion).

Trial design

73 participants in 4 patient groups

12-30 months-old deaf children
Description:
Children with deafness of bilateral deep perception had : Evaluation of the detection of non-linguistic sounds, Early Social Communication Scale (ECSP) and psychomotor infancy development scale or Lézine Brunet-Revised scale
Treatment:
Behavioral: psychomotor infancy development scale
Behavioral: Early Social Communication Scale (ECSP)
Behavioral: Evaluation of the detection of non-linguistic sounds
6-9 years-old deaf children
Description:
Free hearing test categorization and NEPSY (two domains: "memory and learning" and "attention and executive functions") in 6-9 years-old deaf child cohort with deafness of bilateral deep perception and carrying a cochlear implant
Treatment:
Behavioral: Free hearing test categorization
Behavioral: NEPSY (two domains: "memory and learning" and "attention and executive functions").
12-30 months-old normal hearing children
Description:
Evaluation of the detection of non-linguistic sounds in 12-30 months-old normal hearing child cohort
Treatment:
Behavioral: Evaluation of the detection of non-linguistic sounds
6-9 years-old normal hearing children
Description:
'Free hearing test categorization' in 6-9 years-old normal hearing child cohort
Treatment:
Behavioral: Free hearing test categorization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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