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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01284790
Other study ID # 2010-A00439-30
Secondary ID 2009-35
Status Terminated
Phase N/A
First received January 21, 2011
Last updated August 29, 2014
Start date January 2011
Est. completion date March 2012

Study information

Verified date August 2014
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Description:

This study will take place in the ENT department of La Timone hospital in Marseille, where more than 120 adults have been implanted. Our study will comprise several phases, including (1) temporal coding of pitch, (2) spatial coding of pitch, and (3) loudness perception. Eight adult implant users will be recruited for each of these phases.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 .

Exclusion Criteria:

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
Cochlear implants


Locations

Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identify waveforms aimed to improve sound perception by CI recipients 2 YEARS No
Secondary To correlate the results of our measures psychophysiques with recordings électrophysiologiques of the neuronal activity of the hearing nerve. 2 YEARS No