Brain activity imaging to check hearing in children with hearing loss
Tests a light-based brain scan of speech responses in children with hearing loss.
Key facts
- Who runs it
- University Hospital, Lille
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- fNIRS in Pediatric Hearing Aids
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 9 Sept 2021
- Expected to end
- Sept 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- speech audiometry
- Record updated
- 24 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for babies and toddlers with normal hearing, and babies and toddlers with sensorineural hearing loss who wear hearing aids. It tests whether a brain imaging method (fNIRS) can show brain responses to speech.
- Age
- 3 to 18 months
- Sex
- All
- Disease stage
- Hearing aid group: sensorineural hearing loss (hearing loss from the inner ear or hearing nerve). Control group: normal hearing.
- Earlier treatment
- Hearing aid group: must wear a hearing aid in one or both ears, adjusted by a hearing care professional.
Main reasons for not taking part
- A medical condition that makes it impossible to follow the study steps
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- Medical condition that does not allow for research compliance
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- children with hearing aidsTreatment being tested
Treatment: speech audiometry
- control groupSham treatment, for comparison
Treatment: speech audiometry
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)
- Plain-language title
- Brain activity imaging to check hearing in children with hearing lossGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 24 December 2025