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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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