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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02517-50 | Other Identifier | ID-RCB number,ANSM |
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| Name | Class |
|---|---|
| Fondation William Demant | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children with hearing aids | Experimental |
| |
| control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| speech audiometry | Diagnostic Test | 65dB, 55dB or 75dB SPL speech audiometry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenated haemoglobin concentration (HbO) | Baseline (at inclusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Deoxygenated haemoglobin concentration (HbR) | Baseline (at inclusion) | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe VINCENT, PU-PH | Contact | 0320445962 | +33 | christophe.vincent@chru-lille.Fr |
| Name | Affiliation | Role |
|---|---|---|
| Christophe VINCENT, PU-PH | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Roger Salengro, CHU Lille | Recruiting | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D001302 | Audiometry, Speech |
| ID | Term |
|---|---|
| D001299 | Audiometry |
| D006320 | Hearing Tests |
| D003939 | Diagnostic Techniques, Otological |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |