NCT03397147已完成不适用
Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Child Sleep Quality
研究概览
简要总结
Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (HbA1c, % in range), improvements in parent sleep, parental distress, and child behavior problems.
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
- None
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child between 5-9 years of age
- •child have been diagnosed with type 1 diabetes for at least 12 months
- •caregiver lives with child
- •caregiver can read/speak English
排除标准
- •child has other major health problems or sleep disorders other than insufficient sleep or insomnia
- •participating in other intervention studies
结局指标
主要结局
Child Sleep Quality
时间窗: 3 months
Child sleep quality (measured with Child Sleep Habits Questionnaire)
Child Sleep Duration
时间窗: 3 months
Child sleep duration (measured with actigraphy)
次要结局
- Parent Sleep Quality(3 months)
- Child Behavior Problems(3 months)
- Parental Fear of Hypoglycemia(3 months)
- Glycemic Control(3 months)
- Parent Sleep Duration(3 months)
- Parental Diabetes Distress(3 months)
- Parental Well-being(3 months)
研究者
Sarah Jaser
Associate Professor of Pediatrics
Vanderbilt University Medical Center
研究点 (2)
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