fNIRS in Pediatric Hearing Aids

Study Overview
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Brief Summary
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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.

Official Title
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Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)

Conditions
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Hearing Loss

Intervention / Treatment
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* Diagnostic Test: speech audiometry


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: children with hearing aids<br> | Diagnostic Test: speech audiometry<br>* 65dB, 55dB or 75dB SPL speech audiometry<br>|
| Sham Comparator: control group<br> | Diagnostic Test: speech audiometry<br>* 65dB, 55dB or 75dB SPL speech audiometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenated haemoglobin concentration (HbO) |  | Baseline (at inclusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deoxygenated haemoglobin concentration (HbR) |  | Baseline (at inclusion) | 
| HbO Concentration | Evolution of the variation in HbO concentration in the group of infants fitted with a device. | At 3 months, 6 months, 12 months and 24 months | 
| HbR Concentration | Evolution of the variation in HbR concentration in the group of infants fitted with a device. | At 3 months, 6 months, 12 months and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIRS, hearing aid, pediatrics, cochlear implant, rehabilitation, neuroimaging