NCT01023932

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

First QC Date

December 1, 2009

Last Update Submit

December 1, 2009

Conditions

Outcome Measures

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.

Study Arms (1)

Auditory Neuropathy Patients

Device: Cochlear Implants

Interventions

Auditory Neuropathy Patients

Eligibility Criteria

Age2 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children with auditory neuropathy who had received a cochlear implant

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bionic Ear Center

São Paulo, São Paulo, 1150000, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Auditory neuropathy

Interventions

Cochlear Implants

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 2, 2009

Study Start

September 1, 2006

Study Completion

September 1, 2009

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations