fNIRS in Pediatric Hearing Aids

Not Applicable

Recruiting

• Conditions: Hearing Loss
• Interventions: Diagnostic Test: speech audiometry

• Registration Number: NCT04696835
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Study Start: 2021-09-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-16
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
children with hearing aids	speech audiometry	-
control group	speech audiometry	-

Primary Outcome Measures

Name	Time	Method
Oxygenated haemoglobin concentration (HbO)	Baseline (at inclusion)

Secondary Outcome Measures

Name	Time	Method
HbR Concentration	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.
Deoxygenated haemoglobin concentration (HbR)	Baseline (at inclusion)
HbO Concentration	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.

Trial Locations

Locations (1)

Hopital Roger Salengro, CHU Lille; 🇫🇷 Lille, France