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OpenTrials
Completed

NCT Number: NCT01023932

Auditory Neuropathy and Cochlear Implants

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

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bionic Ear Center

São Paulo, 1150000, Brazil

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Cochlear Implants

Device

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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2009
First posted
Dec 2, 2009
Registry last updated
Dec 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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