Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2021-09-09
2027-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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children with hearing aids
speech audiometry
65dB, 55dB or 75dB SPL speech audiometry
control group
speech audiometry
65dB, 55dB or 75dB SPL speech audiometry
Interventions
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speech audiometry
65dB, 55dB or 75dB SPL speech audiometry
Eligibility Criteria
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Inclusion Criteria
* 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
3 Months
18 Months
ALL
No
Sponsors
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Fondation William Demant
UNKNOWN
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Christophe VINCENT, PU-PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hopital Roger Salengro, CHU Lille
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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2019-A02517-50
Identifier Type: OTHER
Identifier Source: secondary_id
2018_73
Identifier Type: -
Identifier Source: org_study_id