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CompletedNCT01023932Updated Dec 2, 2009

Auditory Neuropathy and Cochlear Implants

An observational study in Cochlear Implants and Auditory Neuropathy, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2009-12-02.

Sponsored by University of Sao Paulo · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Ages
2 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Cochlear Implants
  • Auditory Neuropathy
03

In context

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,003 studies on the registry; 88 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Children with auditory neuropathy who had received a cochlear implant

Eligibility criteria

Inclusion Criteria:

  • All children with AN/AD who had received the cochlear implant during the research´s period.
05

Study design

Observational model
Cohort
Time perspective
Prospective

Groups and cohorts

  • Auditory Neuropathy Patients

    Device: Cochlear Implants

Interventions

  • DeviceCochlear Implants
06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • Bionic Ear Center
    Sao Paulo, SP 1150000, Brazil
08

References and documents

Publications

  • de Carvalho ACM, Bevilacqua MC, Sameshima K, Filho OAC. Auditory neuropathy/Auditory dyssynchrony in children with Cochlear Implants. Braz J Otorhinolaryngol. 2011 Jul-Aug;77(4):481-487. doi: 10.1590/S1808-86942011000400012. PubMed 21860975 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01023932
Lead sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted
Dec 2, 2009
Start date
Sep 2006
Completion
Sep 2009
Last update
Dec 2, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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