fNIRS in Pediatric Hearing Aids

Overview

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.

Full Title of Study: “Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2025

Interventions

  • Diagnostic Test: speech audiometry
    • 65dB, 55dB or 75dB SPL speech audiometry

Arms, Groups and Cohorts

  • Experimental: children with hearing aids
  • Sham Comparator: control group

Clinical Trial Outcome Measures

Primary Measures

  • Oxygenated haemoglobin concentration (HbO)
    • Time Frame: Baseline (at inclusion)

Secondary Measures

  • Deoxygenated haemoglobin concentration (HbR)
    • Time Frame: Baseline (at inclusion)
  • HbO Concentration
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 18 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Collaborator
    • Fondation William Demant
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christophe VINCENT, PU-PH, Principal Investigator, University Hospital, Lille
  • Overall Contact(s)
    • Christophe VINCENT, PU-PH, 0320445962, christophe.vincent@chru-lille.Fr

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