NCT07739433尚未招募不适用
Investigating the Neural Oscillatory Features for Limited Access to Oral Language in Deaf Children With Early Bilateral Cochlear Implantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- The beta coefficient of theta-gamma phase-amplitude coupling (PAC) in the linear mixed-effect model
研究概览
简要总结
Children with severe-to-profound congenital hearing loss often experience significant language development challenges. While cochlear implants (CIs) can restore auditory input, outcomes vary widely, even among those who receive implants early (before age 2) and undergo consistent speech therapy. This study aims to identify neural mechanisms underlying these differences.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 4 and 17 years old at time of inclusion
- •Age of first implantation less than or equal to 30 months
- •Bilateral CIs
- •Received CIs simultaneously or sequentially (the interval between two implantations does not exceed 18 months)
- •Congenital severe-to-profound hearing loss (PTA ≥90 dB HL)
排除标准
- •Children with severe associated disabilities who are assessed as unable to complete the tasks
- •Patients who, in the medical opinion of the Investigator, are unlikely to comply with the study protocol
结局指标
主要结局
The beta coefficient of theta-gamma phase-amplitude coupling (PAC) in the linear mixed-effect model
时间窗: at enrollment
language composite score is the dependent variable
次要结局
- Power-spectrum density (PSD) of the EEG resting-state oscillations(at enrollment)
- peak frequencies of the EEG resting-state oscillations(at enrollment)
- Multivariate temporal response functions (mTRF) in audiovisual and audio conditions(at enrollment)
- Comparison of the 40Hz Auditory steady-state responses (ASSR) between participants with or without GJB2 variant(at enrollment)
研究者
相似试验
招募中
不适用
Language Development in Children With Cochlear Implants and Speech-language Therapy InterventionsNCT07447427Assistance Publique - Hôpitaux de Paris60
招募中
不适用
Hearing and Brain Development Cohort in Children and AdolescentsHearing LossNCT07625462Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University5,000
尚未招募
不适用
To study the prevalence of hearing loss in sick newborns at government hospital Kalaburagi using otoacoustic emission testCTRI/2024/06/069685Gulbarga Institute of Medical Sciences150
Unknown
1 期
不同年龄段先天性耳聋患者的听觉脑干植入疗效及中枢可塑性变化的前瞻性队列研究ChiCTR2000036429拨款18
Unknown
不适用
先天性感音神经性耳聋儿童脑功能与结构的多模态 MRI 研究ChiCTR2100047357广西医科大学第一附属医院150