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

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ClinicalTrials.gov Identifier: NCT02539901
Recruitment Status : Completed
First Posted : September 3, 2015
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

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.

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

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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive and Communicative Development Description of Deaf Child With a Cochlear Implant.
Study Start Date : October 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
12-30 months-old deaf children
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
Behavioral: Evaluation of the detection of non-linguistic sounds
Evaluation of the detection of non-linguistic sounds (sound room)

Behavioral: Early Social Communication Scale (ECSP)
Early Social Communication Scale (ECSP) evaluation

Behavioral: psychomotor infancy development scale
Other Name: Lézine Brunet-Revised scale

6-9 years-old deaf children
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
Behavioral: Free hearing test categorization
Free hearing test categorization evaluation

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

12-30 months-old normal hearing children
Evaluation of the detection of non-linguistic sounds in 12-30 months-old normal hearing child cohort
Behavioral: Evaluation of the detection of non-linguistic sounds
Evaluation of the detection of non-linguistic sounds (sound room)

6-9 years-old normal hearing children
'Free hearing test categorization' in 6-9 years-old normal hearing child cohort
Behavioral: Free hearing test categorization
Free hearing test categorization evaluation




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   12 Months to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Young patients consulting in the Unit of Pediatric Cochlear Implantation, Hospital-University Centre of Toulouse.

The normal hearing participants will be recruited by posters, produced in various places childcare (crèches, schools) or pediatric services Purpan hospital.

Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539901


Locations
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France
Hôpital Purpan - Pavillon Dieulafoy - Service ORL (ENT services)
Toulouse, Haute-Garonne, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Olivier DEGUINE, MD, PhD Service ORL - Hôpital Purpan

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02539901     History of Changes
Other Study ID Numbers: 11 227 02
2011-A01058-33 ( Registry Identifier: Agence National du Médicament et des Produits de santé )
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: August 2015

Keywords provided by University Hospital, Toulouse:
cochlear implant
Developmental Psychology
cognitive development
communicative development
perceptual development
deaf child

Additional relevant MeSH terms:
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Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms