Skip to main content
OpenTrials
Completed

NCT Number: NCT02539901

Development of a Deaf Child With a Cochlear Implant.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 month–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Purpan - Pavillon Dieulafoy - Service ORL (ENT services)

Toulouse, Haute-Garonne, 31059, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Evaluation of the detection of non-linguistic sounds

Behavioral

Evaluation of the detection of non-linguistic sounds (sound room)

Free hearing test categorization

Behavioral

Free hearing test categorization evaluation

Early Social Communication Scale (ECSP)

Behavioral

Early Social Communication Scale (ECSP) evaluation

psychomotor infancy development scale

Behavioral

Other names: Lézine Brunet-Revised scale

NEPSY (two domains: "memory and learning" and "attention and executive functions").

Behavioral

NEPSY evaluation

Primary outcomes

  1. screening and diagnosis of global developmental delays in young children

    Time frame: inclusion

  2. evaluation of variation pre-linguistic communication and lexicon emergence

    Time frame: inclusion, 6 months, 12 months and 18 months

Secondary outcomes

  1. Non-linguistic variation of sounds Detection Test

    Time frame: inclusion, 6 months, 12 months and 18 months

  2. Neuropsychological assessment of child development variation

    Time frame: inclusion, 6 months, 12 months and 18 months

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Cognitive and Communicative Development Description of Deaf Child With a Cochlear Implant.

Acronym: DECCODES

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 3, 2015
Registry last updated
Sep 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.