NCT01284790

Brief Summary

Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people worldwide. While most patients show good scores of speech recognition in quiet, a large majority of them also struggle in more challenging listening situations, such as speech in noise or music. This project aims to understand the basic mechanisms of electrical stimulation of the auditory nerve, in order to identify the important cues that the electrical signal should convey and to possible improve sound perception by CI users.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

January 21, 2011

Last Update Submit

August 29, 2014

Conditions

Cochlear Implant Listeners

Outcome Measures

Primary Outcomes (1)

  • Identify waveforms aimed to improve sound perception by CI recipients

    2 YEARS

Secondary Outcomes (1)

  • To correlate the results of our measures psychophysiques with recordings électrophysiologiques of the neuronal activity of the hearing nerve.

    2 YEARS

Study Arms (1)

Cochlear implants

EXPERIMENTAL
Device: Cochlear implants

Interventions

Cochlear implantsDEVICE
Cochlear implants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The adults of more than 18 years old at the beginning of the study without notion of minimal or maximal duration of setting-up(presence).
  • The adults WITH cochlear implant listeners .

You may not qualify if:

  • Presence of intrusive disorders of the personality or mental deficiency. Presence of associated driving disorders. Pregnant or breast-feeding woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Interventions

Cochlear Implants

Intervention Hierarchy (Ancestors)

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

Study Officials

  • BERNARD BELAIGUES

    Assistance Publique hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2011

First Posted

January 27, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

FR(1)