Auditory Neuropathy and Cochlear Implants

Cochlear Implants Clinical Trial

Official title:

Cochlear Implants in Children With Auditory Neuropathy/ Auditory Dys-Synchrony

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023932
• Other study ID #: NADA2009
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: December 1, 2009
• Start date: September 2006
• Est. completion date: September 2009

Study information

• Verified date: December 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2009
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Auditory Neuropathy
• Cochlear Implants
• Hearing Loss, Central

Intervention

Device:
• Cochlear Implants

Locations

Country	Name	City	State
Brazil	Bionic Ear Center	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research.