Auditory Neuropathy and Cochlear Implants

This study has been completed.

Sponsor:

Collaborator:

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01023932

First received: December 1, 2009

Last updated: NA

Last verified: December 2009

History: No changes posted

Purpose

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	Intervention
Cochlear Implants Auditory Neuropathy	Device: Cochlear Implants


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Cochlear Implants in Children With Auditory Neuropathy/ Auditory Dys-Synchrony

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic hearing loss

MedlinePlus related topics: Cochlear Implants

Genetic and Rare Diseases Information Center resources: Auditory Neuropathy

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

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


Study Start Date:	September 2006
Estimated Study Completion Date:	September 2009

Groups/Cohorts	Assigned Interventions
Auditory Neuropathy Patients	Device: Cochlear Implants

Eligibility


Ages Eligible for Study:	2 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Sampling Method:	Non-Probability Sample

Study Population

Children with auditory neuropathy who had received a cochlear implant

Criteria

Inclusion Criteria:

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01023932

Locations


Brazil
Bionic Ear Center
Sao Paulo, SP, Brazil, 1150000

Sponsors and Collaborators

University of Sao Paulo

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Carvalho AC, Bevilacqua MC, Sameshima K, Costa Filho OA. Auditory neuropathy/Auditory dyssynchrony in children with Cochlear Implants. Braz J Otorhinolaryngol. 2011 Jul-Aug;77(4):481-7. English, Portuguese.


Responsible Party:	Ana Claudia Martinho de Carvalho
ClinicalTrials.gov Identifier:	NCT01023932 History of Changes
Other Study ID Numbers:	NADA2009
Study First Received:	December 1, 2009
Last Updated:	December 1, 2009
Health Authority:	Brazil: Ethics Committee

Additional relevant MeSH terms:


Hearing Loss, Central Hearing Loss, Sensorineural Hearing Loss Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Auditory Diseases, Central	Retrocochlear Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Sensation Disorders Neurologic Manifestations Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016

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