HIV/AIDS Clinical Trials

Find HIV/AIDS Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 1
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hopital Roger Salengro, CHU Lille
RECRUITING
Lille
Contact Information
Primary
Christophe VINCENT, PU-PH
christophe.vincent@chru-lille.Fr
0320445962
Time Frame
Start Date: 2021-09-09
Estimated Completion Date: 2027-09
Participants
Target number of participants: 40
Treatments
Experimental: children with hearing aids
Sham_comparator: control group
Related Therapeutic Areas
Sponsors
Collaborators: Fondation William Demant
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov