fNIRS in Pediatric Hearing Aids

NCT04696835 | Recruiting

• 2 other identifiers: 2018_732019-A02517-50
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

NIRS; hearing aid; pediatrics; cochlear implant; rehabilitation; neuroimaging

Outcome Measures

Primary Outcomes (1)

• Oxygenated haemoglobin concentration (HbO)

  Baseline (at inclusion)

Secondary Outcomes (3)

• Deoxygenated haemoglobin concentration (HbR)

  Baseline (at inclusion)

• HbO Concentration

  At 3 months, 6 months, 12 months and 24 months

• HbR Concentration

  At 3 months, 6 months, 12 months and 24 months

Study Arms (2)

children with hearing aids

EXPERIMENTAL

Diagnostic Test: speech audiometry

control group

SHAM COMPARATOR

Diagnostic Test: speech audiometry

Interventions

speech audiometry DIAGNOSTIC_TEST

65dB, 55dB or 75dB SPL speech audiometry

children with hearing aids; control group

Eligibility Criteria

• Age: 3 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Medical condition that does not allow for research compliance.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Fondation William Demant: collaborator

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Interventions

Audiometry, Speech

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Audiometry; Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Christophe VINCENT, PU-PH

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe VINCENT, PU-PH

CONTACT

0320445962; christophe.vincent@chru-lille.Fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 6, 2021
• Study Start: September 9, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)