NCT06479668已完成不适用
Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change micro-awakening index
研究概览
简要总结
The aim of this protocol is to disentangle the links between symptoms of emotion dysregulation, sleep disorders and cognitive deficits by measuring the effects of an emotional induction task on childrens' sleep with autism spectrum disorders (ASD) and attention deficit hyperactivity disorder (ADHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 7 to 12
- •Able to receive clear, age-appropriate information and to participate fully in the study
- •Whose legal representative(s) are able to understand the objectives and risks of the research and to give their dated and signed informed consent.
- •Subjects benefiting from a social health insurance plan (beneficiary of the legal representative(s))
- •With a diagnosis made prior to inclusion of Autism Spectrum Disorder (ASD) or Attention Deficit Disorder with or without Hyperactivity (ADHD) as defined by Diagnostic and Statistical Manual 5 (DSM-5).
- •With abbreviated intelligence quotient > 80 measured by Wechsler Intelligence Scale for Children version IV (WISC-IV )no more than 6 months prior to research inclusion
- •No diagnosis of: fragile X syndrome, Rett syndrome, trisomy 21, tuberous sclerosis of Bourneville, von Recklinghausen disease, Cytomegalovirus encephalitis (CMV encephalitis), congenital rubella, phenylketonuria
- •No clinically significant abnormality which, in the investigator's opinion, could interfere with the implementation of the study.
排除标准
- •- Current or past neurological problem(s) (e.g. stroke, epilepsy, meningitis, head trauma with loss of consciousness of more than 15 min, concussion, brain tumor, ...).
- •tumor, ...)
- •Transmeridian travel (> 2 time zones) in the month prior to study inclusion
- •Presence of a mood disorder (bipolar disorder or depression) according to DSM-5 criteria
- •Social jet-lag > 2 hours (mid-point of sleep differential during weekends vs. weekdays)
- •Modification of psychotropic medication in the 2 months prior to inclusion
- •Use of melatonin-based dietary supplement(s)/medication(s) in the 24 hours prior to study inclusion
- •Use of psychostimulant(s) within 48 hours of study entry
- •Extreme chronotype (Morningness/Eveningness questionnaire score < 10 or > 42)
- •Cognitive-behavioral therapies (CBT) targeting sleep disorders
- •Participation in research involving an experimental drug which may interfere with the protocol*.
- •Minor under guardianship
- •Subject in a period of exclusion (determined by a previous or current study)
- •Subject in emergency situation
研究组 & 干预措施
Autism Spectrum Disorder
Experimental
干预措施: Trier Social Stress Task (Behavioral)
Attention Deficit Disorder with or without Hyperactivity
Experimental
干预措施: Trier Social Stress Task (Behavioral)
结局指标
主要结局
change micro-awakening index
时间窗: At Day 0 and Day 3
polysomnography
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Dreams and BereavementHealthy SubjectsNCT03107403Hospices Civils de Lyon50
终止
不适用
Evaluation of the Links Between Sleep Disorders and the Risk of Suicide AttemptAttempted SuicideNCT03793699University Hospital, Lille24
进行中（未招募）
不适用
Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's DementiaAlzheimer DiseaseMild Cognitive ImpairmentNeuropsychiatric SymptomsSleep DisturbanceNCT04100057Stanford University150
已完成
不适用
Neuroimaging Sleep and Mood in DepressionMajor DepressionNCT05497414Boston University Charles River Campus81
招募中
不适用
The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs StudiesAdverse Childhood ExperiencesVascular DilatationSleepSleep DisturbancePsychosocial StressorPsychological TraumaEndothelial DysfunctionInflammationOxidative StressNCT06454344Nathaniel Jenkins70