fNIRS in Pediatric Hearing Aids (FNIRS)

University Hospital, Lille

Status

Enrolling

Conditions

Hearing Loss

Treatments

Diagnostic Test: speech audiometry

Study type

Interventional

Funder types

Other

Identifiers

NCT04696835

2018_73

2019-A02517-50 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

3 to 18 months old

Volunteers

No Healthy Volunteers

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