Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hearing Loss
- Sponsor
- University Hospital, Lille
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Oxygenated haemoglobin concentration (HbO)
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Oxygenated haemoglobin concentration (HbO)
Time Frame: Baseline (at inclusion)
Secondary Outcomes
- HbR Concentration(At 3 months, 6 months, 12 months and 24 months)
- Deoxygenated haemoglobin concentration (HbR)(Baseline (at inclusion))
- HbO Concentration(At 3 months, 6 months, 12 months and 24 months)