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Auditory Neuropathy and Cochlear Implants
This study has been completed.
Sponsor:
University of Sao Paulo
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01023932
First received: December 1, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
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Purpose
The electrical stimulation generated by the Cochlear Implant (CI) may improve the neural synchrony and hence contribute to the development of auditory skills in patients with Auditory Neuropathy / Auditory Dys-synchrony (AN/AD). Goal: The goal of the research was to evaluate the auditory performance and the characteristics of the electrically evoked compound action potential (ECAP) in a group of 18 cochlear implants recipients with AN/AD.The auditory perception was evaluated by sound field thresholds and speech perception tests. To evaluate ECAP's characteristics, the threshold and amplitude of neural response together with the amplitude growth and recovery functions were evaluated at 80Hz stimulation rate.The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research. The auditory perception benefits as well as the possibility to measure the ECAP showed that the electrical stimulation could compensate the neural dys-synchrony caused by the AN/AD. However, a unique clinical procedure cannot be proposed at this point. Therefore, a careful and complete evaluation of each AN/AD patient before recommending the Cochlear Implant is advised
| Condition | Intervention |
|---|---|
| Cochlear Implants Auditory Neuropathy | Device: Cochlear Implants |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Cochlear Implants in Children With Auditory Neuropathy/ Auditory Dys-Synchrony |
Resource links provided by NLM:
Genetics Home Reference related topics:
nonsyndromic hearing loss
MedlinePlus related topics:
Cochlear Implants
U.S. FDA Resources
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research.
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | September 2009 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Auditory Neuropathy Patients | Device: Cochlear Implants |
Eligibility| Ages Eligible for Study: | 2 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
Children with auditory neuropathy who had received a cochlear implant
Criteria
Inclusion Criteria:
- All children with AN/AD who had received the cochlear implant during the research´s period.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01023932
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023932
Locations
| Brazil | |
| Bionic Ear Center | |
| Sao Paulo, SP, Brazil, 1150000 | |
Sponsors and Collaborators
University of Sao Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ana Claudia Martinho de Carvalho |
| ClinicalTrials.gov Identifier: | NCT01023932 History of Changes |
| Other Study ID Numbers: |
NADA2009 |
| Study First Received: | December 1, 2009 |
| Last Updated: | December 1, 2009 |
Additional relevant MeSH terms:
|
Hearing Loss, Central Hearing Loss, Sensorineural Hearing Loss Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Auditory Diseases, Central |
Retrocochlear Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Sensation Disorders Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on July 21, 2017