fNIRS in Pediatric Hearing Aids (FNIRS)

December 17, 2025 updated by: University Hospital, Lille

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59037
        • Recruiting
        • Hôpital Roger Salengro, CHU Lille
        • Contact:
          • Phone Number: 0320445962

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 1 year (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: control group
Diagnostic test: speech audiometry
65dB, 55dB or 75dB SPL speech audiometry
Experimental: children with hearing aids
Diagnostic test: speech audiometry
65dB, 55dB or 75dB SPL speech audiometry

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deoxygenated haemoglobin concentration (HbR)
Time Frame: Baseline (at inclusion)
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.
At 3 months, 6 months, 12 months and 24 months
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.
At 3 months, 6 months, 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Fondation William Demant

Investigators

  • Principal Investigator: Christophe VINCENT, PU-PH, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_73
  • 2019-A02517-50 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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