Deafness Clinical Trial
— DECCODESOfficial title:
Cognitive and Communicative Development Description of 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.
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). |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Hôpital Purpan - Pavillon Dieulafoy - Service ORL (ENT services) | Toulouse | Haute-Garonne |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05086809 -
Investigation of an Updated Bone-anchored Sound Processor
|
N/A | |
Withdrawn |
NCT02890576 -
Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant COCHLESURV
|
||
Completed |
NCT01256229 -
Outcomes In Children With Developmental Delay And Deafness
|
Phase 1 | |
Recruiting |
NCT04795986 -
First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria
|
||
Recruiting |
NCT05867173 -
Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
|
N/A | |
Completed |
NCT06104813 -
Evaluation of Deaf Men's Knowledge About Sexual Health
|
||
Completed |
NCT04563884 -
Validity of the French Version of Deafness Questionnaires for Children and Adolescents
|
||
Not yet recruiting |
NCT06088953 -
EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER
|
N/A | |
Completed |
NCT03980808 -
American Sign Language-Accessible Diabetes Education
|
N/A | |
Completed |
NCT03694340 -
Optimization of Cochlear Implant MAP-parameters in Children
|
N/A | |
Terminated |
NCT01959152 -
Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
|
N/A | |
Withdrawn |
NCT00604474 -
Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
|
N/A | |
Completed |
NCT00511381 -
Genetic Testing in Detection of Late-Onset Hearing Loss
|
N/A | |
Terminated |
NCT03867058 -
Tradeoff Between Spatial and Temporal Resolution
|
||
Completed |
NCT01109576 -
Workshops for Veterans With Vision and Hearing Loss
|
Phase 0 | |
Completed |
NCT01400178 -
Cochlear Implants in Post-lingually Children: Results After 10 Years
|
N/A | |
Completed |
NCT04106063 -
A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
|
||
Active, not recruiting |
NCT03352154 -
Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants
|
N/A | |
Recruiting |
NCT04495660 -
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
|
N/A | |
Terminated |
NCT02466763 -
Prospective Study of Round Window Versus Cochleostomy Approach to CI Surgery
|
N/A |