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NCT02904187 Clinical Trial

Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults

Deafness Clinical Trial

Official title:
Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02904187
Other study ID # 2008-542
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 17, 2010
Est. completion date March 22, 2016

Study information
Verified date August 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date March 22, 2016
Est. primary completion date March 22, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Positron Emission Tomography (PET)

• Electroencephalogram (EEG)

Locations
Country Name City State
France Département d'ORL, Hôpital Edouard Herriot Lyon cedex 03

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6 months
See also
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Completed NCT01400178 - Cochlear Implants in Post-lingually Children: Results After 10 Years N/A
Completed NCT04106063 - A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
Active, not recruiting NCT03352154 - Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants N/A
Recruiting NCT04495660 - Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS N/A