fNIRS in Pediatric Hearing Aids

Hearing Loss Clinical Trial

— FNIRS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696835
• Other study ID #: 2018_73
• Secondary ID: 2019-A02517-50
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: September 2025

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Christophe VINCENT, PU-PH
• Phone: 0320445962
• Email: christophe.vincent[@]chru-lille.Fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Diagnostic Test:
• speech audiometry
65dB, 55dB or 75dB SPL speech audiometry

Locations

Country	Name	City	State
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Fondation William Demant

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenated haemoglobin concentration (HbO)		Baseline (at inclusion)
Secondary	Deoxygenated haemoglobin concentration (HbR)		Baseline (at inclusion)
Secondary	HbO Concentration	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
Secondary	HbR Concentration	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