Evaluating hearing aid effectiveness in children using brain imaging
Official title: Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)
Run by University Hospital, Lille · NCT04696835 · Data updated 2026-11-12
This study is testing how well hearing aids work for young children with hearing loss by looking at their brain activity when they hear speech.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Months to 18 Months |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | September 9, 2021 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | December 24, 2025 |
| Trial ID | NCT04696835 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include infants and toddlers aged 3 to 18 months, both with normal hearing and those with sensorineural hearing loss fitted with hearing aids.
✕Probably not a fit
Patients with medical conditions that prevent compliance with research protocols may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study investigates the use of functional near-infrared spectroscopy (fNIRS) to assess brain activity in response to speech stimuli in both normo-hearing and deaf children with cochlear implants. It aims to observe hemodynamic changes that indicate brain responses, which could help in understanding the effectiveness of hearing aids in young children. The study is non-controlled and non-randomized, focusing on infants and toddlers aged 3 to 18 months. By utilizing fNIRS, the research seeks to provide insights that could lead to better management strategies for childhood hearing loss.
Why it matters
Potential benefit: If successful, this study could enhance the management and rehabilitation of hearing loss in children, leading to improved auditory outcomes.
How similar studies have gone: While the use of fNIRS in this context is relatively novel, similar studies have shown promise in assessing brain activity related to auditory stimuli.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hopital Roger Salengro, CHU Lille
Lille, France Recruiting
Study contacts
- Principal investigator: Christophe VINCENT, PU-PH — University Hospital, Lille
- Study coordinator: Christophe VINCENT, PU-PH
- Email: christophe.vincent@chru-lille.Fr
- Phone: 0320445962
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.