Hearing Loss
Conditions
Keywords
NIRS, hearing aid, pediatrics, cochlear implant, rehabilitation, neuroimaging
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.
Interventions
DIAGNOSTIC_TESTspeech audiometry
65dB, 55dB or 75dB SPL speech audiometry
Sponsors
Fondation William Demant
University Hospital, Lille
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygenated haemoglobin concentration (HbO) | Baseline (at inclusion) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deoxygenated haemoglobin concentration (HbR) | Baseline (at inclusion) | — |
| HbO Concentration | At 3 months, 6 months, 12 months and 24 months | Evolution of the variation in HbO concentration in the group of infants fitted with a device. |
| HbR Concentration | At 3 months, 6 months, 12 months and 24 months | Evolution of the variation in HbR concentration in the group of infants fitted with a device. |
Countries
France
Contacts
Primary ContactChristophe VINCENT, PU-PH
Outcome results
None listed