跳至主要内容
临床试验/NCT05810636
NCT05810636Enrolling By Invitation不适用

Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
Acceleration

研究概览

简要总结

Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. Clinical diagnosis of this disorder depends of history taking, parent report, and questionnaire. Attention test such as continuous performance test can provide quantitative measurement on attention deficits; however, there is a lack of objective tool to quantify the activity level. This study aims to assess activity level in children with ADHD. We plan to recruit 50 children with ADHD and 50 neurotypical children. The activity level measured by wearable device will be compared between ADHD and neurotypical children. The correlation between behavior rating on questionnaire and quantitative data measured by wearable device will be analyzed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ADHD group:
  • Inclusion criteria:
  • DSM-5 Attention-deficit hyperactivity disorder
  • 7~18 years old
  • Willing to carry smartwatch and smartphone most of the time during one-month study period

排除标准

  • Comorbid with major psychiatric disorders (i.e., schizophrenia, bipolar disorder) or neurodevelopmental disorders (i.e., intellectual disability, autism spectrum disorder)
  • Unable to use smartwatch and smartphone
  • Neurotypical group:
  • Inclusion criteria:
  • 7~18 years old without a diagnosis of Attention-deficit hyperactivity disorder
  • Willing to carry smartwatch and smartphone most of the time during one-month study period
  • Exclusion criteria:
  • Have a diagnosis of major psychiatric disorders (i.e., schizophrenia, bipolar disorder) or neurodevelopmental disorders (i.e., intellectual disability, autism spectrum disorder)
  • Unable to use smartwatch and smartphone

结局指标

主要结局

Acceleration

时间窗: 24 hours for 30 days

Arm Acceleration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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