Auditory Neuropathy and Cochlear Implants

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01023932
• Collaborator: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other)
• Location: 1
• Duration (Months): 36

Study Details

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	Phase
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: Sep 1, 2006
• Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	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

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bionic Ear Center	Sao Paulo	SP	Brazil	1150000

Sponsors and Collaborators

• University of Sao Paulo
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01023932
• Other Study ID Numbers: NADA2009
• First Posted: Dec 2, 2009
• Last Update Posted: Dec 2, 2009
• Last Verified: Dec 1, 2009

• Additional relevant MeSH terms: Hearing Loss, Central

Study Results

No Results Posted as of Dec 2, 2009