| NCT ID | NCT04696835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-09-09 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-09-09 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pilot phase. Monocentric, non-controlled, non-randomized, open-label study evaluating the capacity of the functional near-infrared functional neuroimaging (fNIRS) technique to translate temporal cortical activity in response to a speech stimulus in normo-hearing and deaf children with cochlear implants. Hemodynamic changes are expected to be observed that indicate brain activity following the stimuli, resulting in a change in the concentration of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) recorded by the fNIRS. The use of the FNIRS in the evaluation of hearing aid effectiveness could contribute to a more adapted management of childhood hearing loss since conventional methods in young children are not adapted to the needs of children with hearing loss.
Eligibility Criteria
Inclusion Criteria: * Group A: Infants and toddlers 3-18 months of age who are normal hearing. * Group B: Infants and toddlers aged 3 to 18 months with sensorineural hearing loss fitted with a unilateral or bilateral hearing aid with optimized adjustments by the hearing healthcare professional. * Socially insured subject * Parents or guardians who have given their consent to participate in the study Exclusion Criteria: * Medical condition that does not allow for research compliance.
Contact & Investigator
Christophe VINCENT, PU-PH
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04696835 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 18 Months, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04696835 currently recruiting?
Yes, NCT04696835 is actively recruiting participants. Contact the research team at christophe.vincent@chru-lille.Fr for enrollment information.
Where is the NCT04696835 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT04696835 clinical trial?
NCT04696835 is sponsored by University Hospital, Lille. The principal investigator is Christophe VINCENT, PU-PH at University Hospital, Lille. The trial plans to enroll 40 participants.