- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01023932
Auditory Neuropathy and Cochlear Implants
December 1, 2009 updated by: University of Sao Paulo
Cochlear Implants in Children With Auditory Neuropathy/ Auditory Dys-Synchrony
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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SP
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Sao Paulo, SP, Brazil, 1150000
- Bionic Ear Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with auditory neuropathy who had received a cochlear implant
Description
Inclusion Criteria:
- All children with AN/AD who had received the cochlear implant during the research´s period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Auditory Neuropathy Patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Study Completion
September 1, 2009
Study Registration Dates
First Submitted
December 1, 2009
First Submitted That Met QC Criteria
December 1, 2009
First Posted (Estimate)
December 2, 2009
Study Record Updates
Last Update Posted (Estimate)
December 2, 2009
Last Update Submitted That Met QC Criteria
December 1, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NADA2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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