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NCT Number: NCT04696835

fNIRS in Pediatric Hearing Aids

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

3 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location status: Recruiting

Location contact

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

speech audiometry

Diagnostic Test

65dB, 55dB or 75dB SPL speech audiometry

Primary outcomes

  1. Oxygenated haemoglobin concentration (HbO)

    Time frame: Baseline (at inclusion)

Secondary outcomes

  1. Deoxygenated haemoglobin concentration (HbR)

    Time frame: Baseline (at inclusion)

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe VINCENT, PU-PH

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Fondation William Demant

Registry information

Official study title

Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)

Acronym: FNIRS

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2021
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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