fNIRS in Pediatric Hearing Aids

Recruiting now · Not applicable

Conditions studied: Hearing Loss

In brief

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.

Key facts

Study ID

NCT04696835

Run by

University Hospital, Lille

People needed

40

Starts

2021-09-09

Expected to finish

2027-09-01

Last updated by the study team

2025-12-24

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Medical condition that does not allow for research compliance.

Where it is running

• Hopital Roger Salengro, CHU Lille — Lille, France (enrolling)

Full record on ClinicalTrials.gov

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