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fNIRS in Pediatric Hearing Aids

RecruitingNAAges 3 Months - 18 MonthsAllUniversity Hospital, Lille
NCT04696835 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • speech audiometry
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Where

1 site
Hopital Roger Salengro, CHU Lille
Lille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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