Development of a Deaf Child With a Cochlear Implant.

Deafness Clinical Trial

— DECCODES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539901
• Other study ID #: 11 227 02
• Secondary ID: 2011-A01058-33
• Status: Completed
• Phase: N/A
• First received: August 18, 2015
• Last updated: August 31, 2015
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: August 2015
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 9 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deafness

Intervention

Behavioral:
• Evaluation of the detection of non-linguistic sounds
Evaluation of the detection of non-linguistic sounds (sound room)
• Free hearing test categorization
Free hearing test categorization evaluation
• Early Social Communication Scale (ECSP)
Early Social Communication Scale (ECSP) evaluation
• psychomotor infancy development scale

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

Locations

Country	Name	City	State
France	Hôpital Purpan - Pavillon Dieulafoy - Service ORL (ENT services)	Toulouse	Haute-Garonne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	screening and diagnosis of global developmental delays in young children		inclusion	No
Primary	evaluation of variation pre-linguistic communication and lexicon emergence		inclusion, 6 months, 12 months and 18 months	No
Secondary	Non-linguistic variation of sounds Detection Test		inclusion, 6 months, 12 months and 18 months	No
Secondary	Neuropsychological assessment of child development variation		inclusion, 6 months, 12 months and 18 months	No