- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01284790
Pitch and Loudness Perception by Cochlear Implant Listeners: Psychophysics and Objective Measures
August 29, 2014 updated by: Assistance Publique Hopitaux De Marseille
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cochlear implants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identify waveforms aimed to improve sound perception by CI recipients
Time Frame: 2 YEARS
|
2 YEARS
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To correlate the results of our measures psychophysiques with recordings électrophysiologiques of the neuronal activity of the hearing nerve.
Time Frame: 2 YEARS
|
2 YEARS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
January 21, 2011
First Submitted That Met QC Criteria
January 26, 2011
First Posted (Estimate)
January 27, 2011
Study Record Updates
Last Update Posted (Estimate)
September 1, 2014
Last Update Submitted That Met QC Criteria
August 29, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 2010-A00439-30
- 2009-35 (Other Identifier: CCRRC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cochlear Implant Listeners
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Vanderbilt University Medical CenterEnrolling by invitation
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Vanderbilt University Medical CenterNational Institute on Deafness and Other Communication Disorders (NIDCD)WithdrawnCochlear ImplantUnited States
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Oticon MedicalCompleted
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Szeged UniversityCompleted
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Hospices Civils de LyonRecruiting
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Assiut UniversityNot yet recruitingCochlear Implant
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Mayo ClinicCompletedCochlear ImplantUnited States
Clinical Trials on Cochlear implants
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Manchester University NHS Foundation TrustWithdrawn
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University of Sao PauloCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Completed
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CochlearTerminatedObservation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear (IROS)Hearing LossSpain, South Africa, France, Germany, Netherlands, Turkey, Belgium, Poland, Hungary, Portugal, Sweden, Argentina, Austria, Brazil, Colombia, Slovenia
-
University of OklahomaAmerican Academy of Otolaryngology-Head and Neck Surgery FoundationCompleted
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University of ZurichCompletedHearing Loss, CompleteSwitzerland
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Bnai Zion Medical CenterUnknown
-
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-
Washington University School of MedicineNYU Langone Health; House Clinic, Inc.; Midwest Ear InstituteCompletedHearing LossUnited States
-
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