Auditory Neuropathy and Cochlear Implants | NCT01023932

Studies
Auditory Neuropathy and Cochlear Implants

NCT01023932

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Dec 2, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Cochlear Implants
Auditory Neuropathy

Interventions

Cochlear Implants

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Sep 2009

First Submitted Date

Dec 1, 2009

First Submission Date that Met QC Criteria

Dec 1, 2009

First Posted Date

Dec 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2009

Last Update Posted Date

Dec 2, 2009Estimated

Name	Class
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.	OTHER_GOV

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
Auditory Neuropathy Patients			Device: Cochlear Implants

Name	Type	Description	Arm Group Labels	Other Names
Cochlear Implants	Device		Auditory Neuropathy Patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Children with auditory neuropathy who had received a cochlear implant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bionic Ear Center		São Paulo	São Paulo	1150000	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21860975	Derived	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.

ID	Term
D058117	Neural Prostheses
D058542	Implantable Neurostimulators
D004567	Electrodes, Implanted
D004566	Electrodes