Early, Objective Detection of Autism.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- wave I-VII amplitude
研究概览
简要总结
1- To test the hypothesis that using the SensoDetect Brainstem Evoked Response Audiometry (BERA) technology may be an effective support tool for pediatricians to detect autism.
详细描述
This study will be conducted through two phases:
Phase I: A case-control study.
This will be done at Princess Noura University/ King Abdullah Abdulaziz University Hospital, Riyadh, Kingdom of Saudi Arabia from January 2024 to January 2027.
The SensoDetect BERA technology previously described8,9,13,14 will be used in all parts of the study in the following way:
All recruited participants are to be tested using SensoDetect's patented technology. All tests shall be performed in a quiet and darkened room. Participants will be asked to comfortably sit in an armchair in a resting position (part 1 only). Surface electrodes will then be attached to the skin over the mastoid bones behind the left and right ear, with a ground electrode on one arm. Two reference electrodes will also be placed on the forehead. Before each test session, the procedure shall be fully explained to the test subject or parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •- All patients attending the clinic of Autism.
排除标准
- •Hearing impairment
- •Down syndrome
- •Cerebral Palsy
- •Significant brain damage Intellectual disability.
结局指标
主要结局
wave I-VII amplitude
时间窗: phase 1 of this study one year
Wave I-VII amplitude allow comparison of both groups. Group differences between autistic and totally developed (TD) groups will be tested intra-individually and between groups and presented.
Wave I-VII latencies
时间窗: phase 1 of this study one year
wave I-VII latencies to broaden the perspective and allow a better comparison of both groups. Group differences between autistic and TD groups will be tested intra-individually and between groups and presented.
Wave I-VII interpeak intervals
时间窗: phase 1 of this study one year
Wave I-VII interpeak intervals allow a comparison of both groups. Group differences between autistic and TD groups will be tested intra-individually and between groups and presented.
次要结局
未报告次要终点