跳至主要内容
临床试验/NCT02398214
NCT02398214已完成不适用

A Sleep Hygiene-based Intervention Program for Infants and Toddlers

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
247
试验地点
2
主要终点
Actigraphic assessed sleep quantity variables

研究概览

简要总结

Sleep problems during infancy are associated with behavior and emotional problems, poor language development , parental distress and mood disturbances, and overweight and obese children. The investigators proposed that children who receive the light, activity, and sleep training (LAST) intervention program in this study will have less parent report of problem sleep behaviors and longer duration of nighttime sleep compared to children with no intervention provided.

详细描述

Sleep problems are reported in 71.65% of our nation's infants and toddlers, and the prevalence is much higher than the 20-30% reported in Western countries. The investigators' preliminary findings also show that approximately 53-55% of parents of children between 6 and 12 months of age consider their child sleep a problem with about 4% not knowing whether their child sleep is a problem. Sleep development during infancy is characterized by increasing day-night differences in sleep-wakefulness such as longer bouts of sleep and fewer awakenings at night, and is driven by neurobiological maturation and environmental interactions. By 3 months of age, nearly 58% of infants can sleep continuously between 24:00-05:00 hours. When infants do not sleep through the night by 17 months of age, they are less likely to be able to do so at 29 months of age and beyond. Without proper intervention, sleep problems during infancy can persist to toddler and preschool age. Various interventions have been developed and tested in Western and Asian Countries to address the sleep problems in infants and young children, but none are in Taiwan.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy singleton infant born at gestational age >= 37 weeks

排除标准

  • Infants born before 37 weeks gestation
  • Infants born with a congenital abnormality or a genetic disorder
  • Parents with insufficient Chinese

结局指标

主要结局

Actigraphic assessed sleep quantity variables

时间窗: Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up

Total nighttime, daytime, and 24 hour sleep duration

次要结局

  • Actigraphic assessed sleep quality variables(Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验