Back to resultsCerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
Primary Purpose
Deafness
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Positron Emission Tomography (PET)
Electroencephalogram (EEG)
Sponsored by
About this trial
This is an interventional other trial for Deafness
Eligibility Criteria
Inclusion criteria for patients:
- profoundly deaf patients with bilateral cochlear implants
Exclusion criteria for patients:
- post-operative complications
- incomplete surgical insertion of one of the cochlear implant
- age under 18 years
- non-compliant patient
- pregnant woman or woman with no efficient contraception method
- informed consent not signed
- no health insurance
Inclusion criteria for control
- normal hearing subjects
Exclusion criteria control
- normal hearing subject
- subject under 18 years old
- unilateral or bilateral hearing loss
- non-compliant subject
- pregnant woman or woman with no efficient contraception method
- informed consent not signed
- no health insurance
Sites / Locations
- Département d'ORL, Hôpital Edouard Herriot
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Profound deaf patients
Healthy volunteers
Arm Description
Profound deaf patients with bilateral cochlear implants: Cortical brain activation pattern obtained by PET and EEG
Healthy volunteers: Cortical brain activation pattern obtained by PET and EEG
Outcomes
Primary Outcome Measures
Cortical brain activation pattern
Cortical brain activation pattern obtained by PET or EEG cartography. Activation pattern will be compared between normal hearing subjects and deaf adults with bilateral cochlear implants
Secondary Outcome Measures
Full Information
NCT ID
NCT02904187
First Posted
August 11, 2016
Last Updated
August 26, 2019
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02904187
Brief Title
Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
Official Title
Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 17, 2010 (Actual)
Primary Completion Date
March 22, 2016 (Actual)
Study Completion Date
March 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective to this study is to describe bilateral auditory information processing in profoundly deaf patients with bilateral cochlear implants compared with normal hearing patients. Assumption used is that due to the central consequences of bilateral deafness on binaural auditory information central processing, time between activation of the two cochlear implants is a decisive factor in bilateral implantation compared to unilateral implantation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Profound deaf patients
Arm Type
Other
Arm Description
Profound deaf patients with bilateral cochlear implants: Cortical brain activation pattern obtained by PET and EEG
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers: Cortical brain activation pattern obtained by PET and EEG
Intervention Type
Other
Intervention Name(s)
Positron Emission Tomography (PET)
Intervention Type
Other
Intervention Name(s)
Electroencephalogram (EEG)
Primary Outcome Measure Information:
Title
Cortical brain activation pattern
Description
Cortical brain activation pattern obtained by PET or EEG cartography. Activation pattern will be compared between normal hearing subjects and deaf adults with bilateral cochlear implants
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for patients:
- profoundly deaf patients with bilateral cochlear implants
Exclusion criteria for patients:
post-operative complications
incomplete surgical insertion of one of the cochlear implant
age under 18 years
non-compliant patient
pregnant woman or woman with no efficient contraception method
informed consent not signed
no health insurance
Inclusion criteria for control
- normal hearing subjects
Exclusion criteria control
normal hearing subject
subject under 18 years old
unilateral or bilateral hearing loss
non-compliant subject
pregnant woman or woman with no efficient contraception method
informed consent not signed
no health insurance
Facility Information:
Facility Name
Département d'ORL, Hôpital Edouard Herriot
City
Lyon cedex 03
ZIP/Postal Code
69437
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
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