DeafnessNCT02904187
Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
A study testing Positron Emission Tomography (PET) and Electroencephalogram (EEG) in people with Deafness, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deafness
- What is being tested?
- Positron Emission Tomography (PET) and Electroencephalogram (EEG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2010to 22 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- profoundly deaf patients with bilateral cochlear implants
- normal hearing subjects
Who cannot join
- 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
Show all 14Show fewer
- no health insurance
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Deafness
- Being tested
- Positron Emission Tomography (PET), Electroencephalogram (EEG)
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography (PET)Other
Electroencephalogram (EEG)Other
| Study group | Role | What they receive |
|---|---|---|
| Profound deaf patients | Other | Profound deaf patients with bilateral cochlear implants: Cortical brain activation pattern obtained by PET and EEG Receives: Other: Positron Emission Tomography (PET); Other: Electroencephalogram (EEG) |
| Healthy volunteers | Other | Healthy volunteers: Cortical brain activation pattern obtained by PET and EEG Receives: Other: Positron Emission Tomography (PET); Other: Electroencephalogram (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start17 Mar 2010
- Primary completion22 Mar 2016
- Study completion22 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904187
- Sponsor's protocol ID
- 2008-542
- Status last verified
- Dec 2025
- First submitted
- 11 Aug 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.
PubMed 35943235
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
- ClinicalTrials.gov ID
- NCT02904187
- Acronym / sponsor ID
- 2008-542
- Conditions
- Deafness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Mar 2010 (actual)
- Primary completion
- 22 Mar 2016 (actual)
- Study completion
- 22 Mar 2016 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Profound deaf patients | Other | Other: Positron Emission Tomography (PET), Other: Electroencephalogram (EEG)Profound deaf patients with bilateral cochlear implants: Cortical brain activation pattern obtained by PET and EEG |
| Healthy volunteers | Other | Other: Positron Emission Tomography (PET), Other: Electroencephalogram (EEG)Healthy volunteers: Cortical brain activation pattern obtained by PET and EEG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- profoundly deaf patients with bilateral cochlear implants
- normal hearing subjects
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron Emission Tomography (PET) | Other | Healthy volunteers, Profound deaf patients |
| Electroencephalogram (EEG) | Other | Healthy volunteers, Profound deaf patients |
Primary outcome
Cortical brain activation pattern
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 35943235Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positron Emission Tomography (PET) and Electroencephalogram (EEG) in people with Deafness, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical brain activation pattern (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02904187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.