the Effects of Sleep Intervention in Children With Autism Spectrum Disorder Through Synchronized Eye-tracking and Functional Near-infrared Spectroscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- congnitive-neural outcomes
研究概览
简要总结
Sleep disturbance is very common in children with autism spectrum disorder (ASD),and closely associated with their core symptom, social deficit.This trial investigates the effects of Cognitive behaviour therapy for insomnia (CBT-I) in children with autism spectrum disorder with sleep problems through synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS). This is a 1:1 parallel single-blind randomized controlled trial.
详细描述
sleep disturbance is significantly associated with social deficit of ASD and but the congnitive-neural mechanism underlying this association remains unclear. Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia. After 5 consecutive sleep interventions is a 2-year following up study, the above issue is further tested with emphasis on progressive trajectory from a developmental perspective. we examine the influence of sleep disturbance on face processing and neural response during naturalistic social behavior of ASD children using synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS) to uncover the neural mechanism for that sleep disturbance influences social deficit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant blind
入排标准
- 年龄范围
- 24 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet the diagnostic criteria for autism DSM-5 and ADOS-2;
- •age 24months to 59months s old;
- •willing to participate in this study, and can complete the following assessments at the specific time.
排除标准
- •Exclusion of severe respiratory diseases, schizophrenia, epilepsy and other brain diseases;
结局指标
主要结局
congnitive-neural outcomes
时间窗: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
The investigators examine the influence of sleep disorders on face processing and neural response at baseline, 6 months after the intervention, 12 months after the intervention and when children 6 year olds by synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS) to uncover the neural mechanism for that sleep disturbance influences social-emotional development.
ADOS-2
时间窗: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
The ADOS-2 is the standard instrument for assessing autism spectrum disorders (ASD) across age, developmental level, and language skills.
次要结局
- Sleep diaries by using Actigraphy(changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds)
研究者
Sijia Gu
staff of Research Department
Shanghai Jiao Tong University School of Medicine