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Not yet recruitingNCT07739433ICOUpdated Jul 31, 2026

Investigating the Neural Oscillatory Features for Limited Access to Oral Language in Deaf Children With Early Bilateral Cochlear Implantation

An observational study in Congenital Hearing Loss and Bilateral Cochlear Implants, sponsored by Institut Pasteur. Not yet recruiting. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Institut Pasteur · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
4 Years to 17 Years
Sex
All
01

Study 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. This study aims to identify neural mechanisms underlying these differences.

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Conditions studied

  • Congenital Hearing Loss
  • Bilateral Cochlear Implants

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03

In context

Hearing Loss

796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 192 observational studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Institut Pasteur is the lead sponsor of 99 studies on the registry; 41 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The beta coefficient of theta-gamma phase-amplitude coupling (PAC) in the linear mixed-effect model

    language composite score is the dependent variable

    Time frame: at enrollment

Secondary outcomes

  1. Power-spectrum density (PSD) of the EEG resting-state oscillations

    Time frame: at enrollment

  2. peak frequencies of the EEG resting-state oscillations

    Time frame: at enrollment

  3. Multivariate temporal response functions (mTRF) in audiovisual and audio conditions

    Time frame: at enrollment

  4. Comparison of the 40Hz Auditory steady-state responses (ASSR) between participants with or without GJB2 variant

    Time frame: at enrollment

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 98 observational studies under Hearing Loss, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 83. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2026
First posted
Jul 31, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2028
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07739433
Lead sponsor
Institut Pasteur
Responsible party
Sponsor
First posted
Jul 31, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Jul 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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