Clinical Trials Logo

Clinical Trial Summary

The principal aim of this study is to evaluate the cortical developement of perceptual skills and executive functions over time, in children with cochlear implants aged 10-24 months and 3-7 years compared with normally hearing subjects (NHS). To do this, the investigator will use functional Near InfraRed Spectroscopy (fNIRS) during 4 tasks that engage the childs perceptual and cognitive skills over a period of 18 months. The performance scores obtained by each participants as well as the cortical activity will be analysed and decrypted.


Clinical Trial Description

When confronted with a severe to profound congenital bilateral hearing loss, cochlear implantation is considered to be the preferential treatment method as it restaures auditory function and enables language acquisition for communication purposes. When cochlear implantation is done before 2 and a half years old, better results are obtained in terms of language, communication and social developement, as well as reading skills. However when a cochlear implantation occurs between 2 and 5 years of age, speech and language skills do develop but communication and reading skills are altered. Therefore, when a cochlear implant is placed before the age of 2 and a half we find ourselves within the maximal cerebral plasticity window for speech, language and communication developement. This study is divided into two cohorts, the first aged 10-24 months and the second 3-7 years. All children will be seen for 5 sessions, spread out at regular intervals, over a period of 18 months and will participate in two perceptual tasks and two cognitive tasks. The children will also have a speech and language assessment at T-0 and T+12. The cochlear implanted patients will continue to be seen by the ENT service and the sessions will be organised to coincide with their natural follow up. As it is a non-interventional study, no follow-up would be needed. After the study patients will continue to receive the same quality of care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04495660
Study type Interventional
Source University Hospital, Toulouse
Contact Yohan GALLOIS, MD
Phone 5 61 77 85 97
Email gallois.y@chu-toulouse.fr
Status Recruiting
Phase N/A
Start date May 29, 2020
Completion date June 3, 2026

See also
  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Withdrawn NCT02890576 - Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant COCHLESURV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
Completed NCT02539901 - Development of a Deaf Child With a Cochlear Implant. N/A
Completed NCT00511381 - Genetic Testing in Detection of Late-Onset Hearing Loss N/A
Withdrawn NCT00604474 - Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants 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
Terminated NCT02466763 - Prospective Study of Round Window Versus Cochleostomy Approach to CI Surgery N/A