NCT00989950已完成不适用
Open Label Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Sleep Latency
研究概览
简要总结
Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana (methylphenidate) patch for a longer time then 9 hours, many children report short sleep latencies and better quality of sleep.
详细描述
Once the optimal dose of Daytrana that controlled the ADHD symptoms is established. The patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly intervals, and parents will keep a sleep diary.
25 patients will be enrolled in order to obtain statistical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADHD without significant comorbidity
排除标准
- •Cardiac disorder
- •Hypertension
- •Thyroid disease
- •History of sudden death, motor tics and/or Tourette's syndrome
- •Hypersensitivity to methylphenidate
研究组 & 干预措施
Daytrana 9 hr wear
Experimental
干预措施: Daytrana (Drug)
Daytrana 10 hr wear
Experimental
干预措施: Daytrana (Drug)
Daytrana 11 hr wear
Experimental
干预措施: Daytrana (Drug)
Daytrana 12 hr wear
Experimental
干预措施: Daytrana (Drug)
结局指标
主要结局
Sleep Latency
时间窗: 9 weeks
Measure by daily subject sleep diary
次要结局
未报告次要终点
研究者
Arie Ashkenasi, MD
Staff Neurologist
Cox Health Systems
研究点 (1)
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