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临床试验/NCT03419871
NCT03419871已完成不适用

Sleep, Biological Stress, and Health Among Toddlers Living in Socioeconomically Disadvantaged Homes

Yale University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Caregiver report

研究概览

简要总结

A longitudinal study to examine the relationships among sleep characteristics, stress, and child behavior problems in a community sample of toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes

详细描述

The purpose of this study is to examine the relationships among sleep characteristics, stress (allostatic load), and health among toddlers living in economically stressed communities. Sleep difficulty, including short sleep duration and poor sleep efficiency, is closely related to measures of stress, including interleukin (IL-6), cortisol, c-reactive proteins (CRP), secretory immunoglobulin A (SIgA), and body mass index (BMI) and may therefore contribute to 'wear and tear' on the body (allostatic load), a problem that places children at high risk of physical and mental health problems. Young children who live with socioeconomic adversity are especially vulnerable to both sleep difficulty and higher levels of physiologic stress (allostatic load).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Months 至 15 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.

排除标准

  • If the toddler has a diagnosis of sleep apnea or has another documented medical condition affecting sleep.

结局指标

主要结局

Caregiver report

时间窗: 12 to 36 months

Caregivers will complete the Brief Infant Sleep Questionnaire

Behavioral monitoring

时间窗: 12 to 36 months

Toddler behavior problems will be assessed using the Brief Infant Toddler Social and Emotional Assessment (BITSEA).

Sleep monitoring

时间窗: 9 days

Sleep characteristics will be measured by an accelerometer on the wrist or ankle to measure sleep efficiency.

Sleep diary

时间窗: 12 to 24 months

Caregivers will complete a sleep diary to record their toddler's sleep for time period when an accelerometer will be worn by the child.

次要结局

  • Immune biomarkers(12 to 24 months)
  • Anthropometric biomarkers(12 to 24 months)
  • Cortisol biomarker(12 to 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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