Actively Recruiting

Phase Not Applicable
Age: 3Months - 18Months
All Genders
NCT04696835

fNIRS in Pediatric Hearing Aids

Led by University Hospital, Lille · Updated on 2025-12-24

40

Participants Needed

1

Research Sites

311 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Lille

Lead Sponsor

F

Fondation William Demant

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

fNIRS in Pediatric Hearing Aids

Who Can Participate

Age: 3Months - 18Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants and toddlers aged 3 to 18 months with normal hearing
  • Infants and toddlers aged 3 to 18 months with sensorineural hearing loss using unilateral or bilateral hearing aids adjusted by a hearing professional
  • Socially insured subjects
  • Parents or guardians have given consent to participate in the study
Not Eligible

You will not qualify if you...

  • Medical condition preventing compliance with research procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hopital Roger Salengro, CHU Lille

Lille, France, 59037

Actively Recruiting

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Research Team

C

Christophe VINCENT, PU-PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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