Hearing LossFNIRSNCT04696835
fNIRS in Pediatric Hearing Aids
A study testing speech audiometry in people with Hearing Loss, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 months
- Conditions the study is for
- Hearing Loss
- What is being tested?
- speech audiometry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2021to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- Medical condition that does not allow for research compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Roger Salengro, CHU Lille
Lille, 59037
0320445962
About this study
Official title: Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)
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.
- Conditions
- Hearing Loss
- Being tested
- speech audiometry
- Keywords
- NIRS, hearing aid, pediatrics, cochlear implant, rehabilitation, neuroimaging
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech audiometryDiagnostic test
65dB, 55dB or 75dB SPL speech audiometry
| Study group | Role | What they receive |
|---|---|---|
| children with hearing aids | Experimental | Not described Receives: Diagnostic Test: speech audiometry |
| control group | Sham comparator | Not described Receives: Diagnostic Test: speech audiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenated haemoglobin concentration (HbO)
Measured: Baseline (at inclusion)
Secondary outcomes (3)
Deoxygenated haemoglobin concentration (HbR)
Measured: Baseline (at inclusion)
HbO Concentration
Evolution of the variation in HbO concentration in the group of infants fitted with a device.
Measured: 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.
Measured: At 3 months, 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start9 Sep 2021
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation William Demant
- Responsible party
- Sponsor
- Investigators
- Christophe VINCENT, PU-PH, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696835
- Sponsor's protocol ID
- 2018_73
- Other IDs
- 2019-A02517-50
- Acronym
- FNIRS
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2021
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)
- ClinicalTrials.gov ID
- NCT04696835
- Acronym / sponsor ID
- FNIRS / 2018_73
- Conditions
- Hearing Loss
- Keywords
- NIRS, hearing aid, pediatrics, cochlear implant, rehabilitation, neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Fondation William Demant
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with hearing aids | Experimental | Diagnostic Test: speech audiometry |
| control group | Sham comparator | Diagnostic Test: speech audiometry |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Medical condition that does not allow for research compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speech audiometry65dB, 55dB or 75dB SPL speech audiometry | Diagnostic test | children with hearing aids, control group |
Primary outcome
Oxygenated haemoglobin concentration (HbO)
Time frame: Baseline (at inclusion)
3 secondary outcomes
Deoxygenated haemoglobin concentration (HbR)
Time frame: Baseline (at inclusion)
HbO Concentration
Time frame: At 3 months, 6 months, 12 months and 24 months
HbR Concentration
Time frame: At 3 months, 6 months, 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christophe VINCENT, PU-PH principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speech audiometry in people with Hearing Loss, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe VINCENT, PU-PH (0320445962 ext. +33, christophe.vincent@chru-lille.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenated haemoglobin concentration (HbO) (time frame: Baseline (at inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.