Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Oxygenated haemoglobin concentration (HbO)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Medical condition that does not allow for research compliance.
结局指标
主要结局
Oxygenated haemoglobin concentration (HbO)
时间窗: Baseline (at inclusion)
次要结局
- HbR Concentration(At 3 months, 6 months, 12 months and 24 months)
- Deoxygenated haemoglobin concentration (HbR)(Baseline (at inclusion))
- HbO Concentration(At 3 months, 6 months, 12 months and 24 months)