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Auditory Neuropathy and Cochlear Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01023932
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cochlear Implants Auditory Neuropathy Device: Cochlear Implants

Study Design

Study Type : Observational
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cochlear Implants in Children With Auditory Neuropathy/ Auditory Dys-Synchrony
Study Start Date : September 2006
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Auditory Neuropathy Patients Device: Cochlear Implants

Outcome Measures

Primary Outcome Measures :
  1. The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research.

Eligibility Criteria

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • All children with AN/AD who had received the cochlear implant during the research´s period.
Contacts and Locations

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): NCT01023932

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
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 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