Experimental Effects of Children's Evening Media Use on Circadian Phase, Sleep and Executive Functioning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Change in Dim light Melatonin Onset Phase
研究概览
简要总结
To test the timing of evening tablet use on children's circadian phase and sleep (i.e., sleep onset and sleep duration) compared to no screen media use. To explore the effect of evening tablet use on children's inhibitory control and executive function.
详细描述
The goal of the study is to test the effect of tablet use before bed on the sleep, circadian phase, and executive functioning (EF) of 4-year-olds using a 3-group randomized controlled trial in which children are assigned to receive one of 2 experimental conditions (Group A:1 hour of tablet use in the hour before bed; Group B:1 hour of tablet use 2 hours before bed) or a control condition (no evening screen media use). It is hypothesized that in comparison to no tablet use, daily exposure to tablet use before bed will be associated with a delay in children's circadian phase (e.g., occurring later in the evening/night), a longer sleep latency (i.e., later sleep onset), and shorter sleep duration. It is anticipated that tablet use in the hour before bed will have a greater impact on children's circadian phase and sleep than tablet use 2 hours before bed, or no tablet use before bed. We will explore whether changes in circadian phase and sleep result in poorer performance on measures of EF (i.e., inhibitory control and working memory).
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
- Single (Investigator)
盲法说明
Blinding of the study biostatistician and PI during the analysis will be ensured. Groups will be denoted by a variable that does not reveal its identity. The blinding will be broken after the data set is closed and analyses completed.
入排标准
- 年龄范围
- 48 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •preschool-aged children (4.0 to <5.0 years old) and their parent
- •living in the Greater Houston area.
- •parent must be a biological parent or legal guardian who lives with the child ≥50% of the time and has a primary role of caring for the child
- •parent is comfortable participating in the study and responding to questionnaires in English.
- •The child does not have to have access to mobile device, but if they do, the primary device they use has to be an Android OS ≥5.0 either used only by the study child or shared with others, or an Apple iOS ≥14.0 that only the child uses.
- •Parent and child must be fluent in English.
排除标准
- •The child has a chronic medical condition or takes a medication affecting sleep, or circadian rhythms (e.g., melatonin supplementation, diagnosed sleep disorder, steroid use, etc.) or a diagnosed cognitive or learning impairment affecting EF (e.g., attention deficit hyperactivity disorder).
- •Child with blindness or significant vision problems that impacts both screen media use and sleep.
研究组 & 干预措施
Group A: 1 hour of tablet use in the hour before bed
During week 1, children will maintain a sleep schedule within 30 minutes +/- of their habitual bedtime. This bedtime will be maintained throughout the 3 weeks of the study except on nights when dim light melatonin onset is assessed in the lab.
During week 2, participants will be asked to reframe from screen use in the 3 hours before bed time for 6 evenings.
During week 3, participants will be exposed to 1 hour of tablet use (Standard bright setting), 1 hour before bedtime for 6 evenings.
干预措施: Timed evening technology and digital media use (tablet use) (Behavioral)
Group B: 1 hour of tablet use 2 hours before bed
During week 1, children will maintain a sleep schedule within 30 minutes +/- of their habitual bedtime. This bedtime will be maintained throughout the 3 weeks of the study except on nights when dim light melatonin onset is assessed in the lab.
During week 2, participants will be asked to reframe from screen use in the 3 hours before bedtime for 6 evenings.
During week 3, participants will be exposed to 1 hour of tablet use (Standard bright setting), 2 hours before bedtime (and no screen use in the hour before bed) for 6 evenings.
干预措施: Timed evening technology and digital media use (tablet use) (Behavioral)
Control Condition
During week 1, children will maintain a sleep schedule within 30 minutes +/- of their habitual bedtime. This bedtime will be maintained throughout the 3 weeks of the study except on nights when dim light melatonin onset is assessed in the lab.
During week 2, participants will engage no screen use for the 3 hours before bedtime for 6 evenings.
During week 3, participants will be asked to engage in no screen use in the 3 hours before bedtime for 6 evenings.
干预措施: no technology and digital media use (screen media use) (Behavioral)
结局指标
主要结局
Change in Dim light Melatonin Onset Phase
时间窗: Day 14 to Day 21
Circadian phase can be examined by measuring the circadian timing of melatonin onset under dim light conditions (dim light melatonin onset; DMLO). Compared to markers of endogenous circadian rhythms, melatonin is relatively robust. Salivary DLMO measures have demonstrated high intraclass correlations (.93) with plasma and sensitivity and specificity comparable to plasma assays. Following established procedures with children, salivary DLMO will be collected on a in the laboratory under dim light conditions (\<5 lux), via a cheek swab every 30-60 minutes beginning 5 hours prior to and ending 1-hour following typical bedtime. Saliva samples will be centrifuged, frozen, and assayed using radioimmunoassay test kits by Solid Phase in Portland Me. DLMO phase will be determined using linear interpolation across the time points before and after melatonin concentration increased to and remained above 4pg/mL.
次要结局
- Change in the Average Sleep Onset(Day 9 through 13 and Day 16 through 20)
- Change in Average Sleep duration(Day 9-13 and Day 16-20)
- Change in Inhibitory Control-Grass/Snow(Day 14 or Day 21)
- Change in Inhibitory Control-Day/Night(Day 14 or Day 21)
- Change in combined assessment of Executive Functioning working memory and inhibitory control(Day 14 to Day 21)
- Change in Working memory(Day 14 to Day 21)
研究者
Jennette P. Moreno, PhD
Assistant Professor, Pediatrics - Nutrition
Baylor College of Medicine