Congenital Hearing LossICONCT07739433
Investigating the Neural Oscillatory Features for Limited Access to Oral Language in Deaf Children With Early Bilateral Cochlear Implantation
An observational study of Congenital Hearing Loss and Bilateral Cochlear Implants, run by Institut Pasteur.
Trial summary
Children with severe-to-profound congenital hearing loss often experience significant language development challenges. While cochlear implants (CIs) can restore auditory input, outcomes vary widely, even among those who receive implants early (before age 2) and undergo consistent speech therapy. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Congenital Hearing Loss, Bilateral Cochlear Implants
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will involve minors (between 4 and 17 years-old) with congenital severe-to-profound hearing loss with early bilateral CIs from pediatric ENT department of Necker hospital in Paris.
Who may be able to join
- Between 4 and 17 years old at time of inclusion
- Age of first implantation less than or equal to 30 months
- Bilateral CIs
- Received CIs simultaneously or sequentially (the interval between two implantations does not exceed 18 months)
- Congenital severe-to-profound hearing loss (PTA ≥90 dB HL)
Who cannot join
- Children with severe associated disabilities who are assessed as unable to complete the tasks
- Patients who, in the medical opinion of the Investigator, are unlikely to comply with the study protocol
About this study
Children with severe-to-profound congenital hearing loss often experience significant language development challenges. While cochlear implants (CIs) can restore auditory input, outcomes vary widely, even among those who receive implants early (before age 2) and undergo consistent speech therapy. This study aims to identify neural mechanisms underlying these differences.
What is being measured
The primary outcome is the main question the study is designed to answer.
The beta coefficient of theta-gamma phase-amplitude coupling (PAC) in the linear mixed-effect model
language composite score is the dependent variable
Measured: at enrollment
Secondary outcomes (4)
Power-spectrum density (PSD) of the EEG resting-state oscillations
Measured: at enrollment
peak frequencies of the EEG resting-state oscillations
Measured: at enrollment
Multivariate temporal response functions (mTRF) in audiovisual and audio conditions
Measured: at enrollment
Comparison of the 40Hz Auditory steady-state responses (ASSR) between participants with or without GJB2 variant
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Hearing LossStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739433
- Sponsor's protocol ID
- 2025-067
- Acronym
- ICO
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neural Oscillatory Features for Limited Access to Oral Language in Deaf Children With Early Bilateral Cochlear Implantation
- ClinicalTrials.gov ID
- NCT07739433
- Acronym / sponsor ID
- ICO / 2025-067
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- 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.
Children with severe-to-profound congenital hearing loss often experience significant language development challenges. While cochlear implants (CIs) can restore auditory input, outcomes vary widely, even among those who receive implants early (before age 2) and undergo consistent speech therapy. This study aims to identify neural mechanisms underlying these differences.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will involve minors (between 4 and 17 years-old) with congenital severe-to-profound hearing loss with early bilateral CIs from pediatric ENT department of Necker hospital in Paris.
Key inclusion criteria (5 listed)
- Between 4 and 17 years old at time of inclusion
- Age of first implantation less than or equal to 30 months
- Bilateral CIs
- Received CIs simultaneously or sequentially (the interval between two implantations does not exceed 18 months)
- Congenital severe-to-profound hearing loss (PTA ≥90 dB HL)
Key exclusion criteria (2 listed)
- Children with severe associated disabilities who are assessed as unable to complete the tasks
- Patients who, in the medical opinion of the Investigator, are unlikely to comply with the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The beta coefficient of theta-gamma phase-amplitude coupling (PAC) in the linear mixed-effect model
Time frame: at enrollment
language composite score is the dependent variable
4 secondary outcomes
Power-spectrum density (PSD) of the EEG resting-state oscillations
Time frame: at enrollment
peak frequencies of the EEG resting-state oscillations
Time frame: at enrollment
Multivariate temporal response functions (mTRF) in audiovisual and audio conditions
Time frame: at enrollment
Comparison of the 40Hz Auditory steady-state responses (ASSR) between participants with or without GJB2 variant
Time frame: at enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hearing Loss and Bilateral Cochlear Implants, run by Institut Pasteur.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The beta coefficient of theta-gamma phase-amplitude coupling (PAC) in the linear mixed-effect model (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.