Experimental Effects of Light And Content From Evening Screen Media Use On Children's Sleep, Executive Functioning, And Emotion Regulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Differences in Subjective Sleep Quality on nights following the experimental and internal negative
研究概览
简要总结
The proposed project aims to disentangle the impact of evening light exposure emitted from tablet devices from the impact of arousing media content on children's sleep regulation, circadian physiology and next-day emotion regulation and executive functioning.
详细描述
Investigators will conduct a 4-group randomized, controlled trial including 200 children (8 to 11 years; Tanner stage 1 or 2) assigned to an unfiltered bright light screen (BL; 109 lux) or a dim light screen (DL; <5 lux) condition in room lighting (40-50 lux) matched with either calming (CC) or exciting content (EC). Children will participate in two weekend protocols, an experimental and a control weekend. During the experimental weekend, children will be exposed to 1 hour of tablet use in the hour before bed under the following conditions: 1) unfiltered bright screen light and exciting content (BL/EC), 2) unfiltered bright screen light and calming content (BL/CC) 3) filtered dim screen light and exciting content (DL/EC) and 4) filtered dim screen light and calming content (DL/CC). To control for the effect of screen media which is common to all 4 conditions irrespective of screen brightness and the nature of the content, each child will undergo a "control condition weekend" in which the child will participate in the same weekend study protocol, but instead of using screen media in the hour before bed, children will participate in non-screen based quiet activities in room lighting (40-50 lux). The control condition will serve as a negative internal control. The order in which children are exposed to the experimental or control weekends will be randomized (i.e., counterbalanced) to control for possible order effects.
Following a week of typical sleep and media use, a 3-day weekend protocol will be implemented in the home facilitated by research staff on two occasions (one week apart, counterbalanced). To assess a potential shift in circadian phase, dim light melatonin onset (DLMO; time at which melatonin level rise above 4pg/mL) will be assessed by research staff on Nights 1 and 3 of the weekend protocol via saliva samples collected under tightly-controlled dim light conditions (i.e., DLMO-Night 3 to DLMO-Night 1). To facilitate the assessment of circadian phases under dim light conditions (<5 lux), research staff will place temporary covers over windows and adjust the lighting in the child's bedroom. A light meter will be used to ensure appropriate lighting conditions.
On Night 2, children will be exposed to either the experimental condition to which they were assigned or the control condition. A background of room lighting (40-50 lux) will be common to both the experimental and control condition.
During the experimental condition, children will exposed to screen media according to the experimental condition they were assigned (BL/EC, BL/CC, DL/EC, DL/CC) via a handheld tablet (at eye level, 45 cm in front of the child). To standardize the distance of the iPad from the eye across participants, the tablet (or non-screen-based activity) will be placed on an adjustable bed desk at a distance of 45cm from the eye. Children will sit upright in bed with a pillow behind them. Assessments on Night 2, will be as follows: 1) children's sleep will be assessed via actigraphy, 2) children's arousal will be assessed via heart rate (HR), and heart rate variability (HRV) 3)subjective sleepiness ratings will be collected before the start of the experimental condition, after 30 minutes, and again at bedtime. 4) ambient light will be assessed via a light sensor clipped onto the shirt collar. Thenext afternoon, emotion regulation (subjective reports and respiratory sinus arrhythmia; RSA) and executive functioning (neurocognitive testing) will be measured to assess these secondary outcomes. Research staff (in teams of 2) will be present in the home to conduct the circadian phase assessments, administer the experimental conditions on the Night 2, and to conduct the executive functioning and emotion regulation assessments in the afternoon of Night 3.
During the weekend protocols, children will be able to participate in daytime activities as usual with the exception that on days when melatonin is assessed, children will be asked to refrain from strenuous physical activity as this is known to affect melatonin.
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
The investigators will be blinded to treatment condition in the analysis of outcomes
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children between 8.0 and 11.9 year old
- •Tanner stage 1 and 2
- •live with their parent(s) (biological or legal guardian at least 50% of the time and has a primary role of caring for the child).
- •Children who sleep between 8.5 to 11 hours per night habitually
- •Children must sleep alone most nights
- •parent and child able to communicate and read and write in English
- •The child does not have to have access to a mobile device (tablet or Phone), but if they do, the primary device they use has to be an a) Android OS ≥5.0 either used only by the study child or shared with others, b) Amazon Fire OS ≥5.0 that only the child uses or c) an Apple iOS ≥14.0 that only the child uses.
- •If the child's primary device is a Android or Amazon Fired device, the parent and child agree to install Chronicle App (Android or Amazon). If the child's primary device is an Apple device, the parent and child agree to allow us to gather usage screenshots from the primary iPad or iPhone.
- •Families must live in the greater Houston area.
排除标准
- •child blindness or colorblindness
- •significant vision problems
- •developmental or cognitive delays
- •diagnosis of a sleep or psychiatric disorder
- •diagnosed cognitive or learning impairment affecting executive functioning (e.g., attention deficit hyperactivity disorder)
- •medical conditions that impact sleep
- •taking medications that impact sleep
- •travel beyond 2 time zones in the month before starting the study
研究组 & 干预措施
Group 1
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 1 will be exposed to a tablet with unfiltered bright screen light and exciting media content (BL/EC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: no screen control with dim light and calming activities (Behavioral)
Group 1
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 1 will be exposed to a tablet with unfiltered bright screen light and exciting media content (BL/EC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: unfiltered Bright tablet screen (Behavioral)
Group 1
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 1 will be exposed to a tablet with unfiltered bright screen light and exciting media content (BL/EC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: Exciting content (Behavioral)
Group 2
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 2 will be exposed to a tablet with unfiltered bright screen light and calming media content (BL/CC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: no screen control with dim light and calming activities (Behavioral)
Group 2
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 2 will be exposed to a tablet with unfiltered bright screen light and calming media content (BL/CC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: unfiltered Bright tablet screen (Behavioral)
Group 2
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 2 will be exposed to a tablet with unfiltered bright screen light and calming media content (BL/CC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: Calming Content (Behavioral)
Group 3
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 3 will be exposed to a tablet with filtered dim screen light and exciting media content (DL/EC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: no screen control with dim light and calming activities (Behavioral)
Group 3
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 3 will be exposed to a tablet with filtered dim screen light and exciting media content (DL/EC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: Filtered dim tablet screen (Behavioral)
Group 3
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 3 will be exposed to a tablet with filtered dim screen light and exciting media content (DL/EC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: Exciting content (Behavioral)
Group 4
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 4 will be exposed to a tablet with filtered dim screen light and calming media content (DL/CC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: no screen control with dim light and calming activities (Behavioral)
Group 4
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 4 will be exposed to a tablet with filtered dim screen light and calming media content (DL/CC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: Filtered dim tablet screen (Behavioral)
Group 4
Children will participate in 2 exposure conditions in their own homes (i.e., experimental and internal negative control), facilitated by research staff (one week apart, counterbalanced to control for possible order effects). The internal negative control will be the same for all groups, but the experimental exposure will differ. Both exposures will take place for 1 hour before bed in room lighting (40-50 lux).
Experimental exposure: children in Group 4 will be exposed to a tablet with filtered dim screen light and calming media content (DL/CC).
Internal negative control exposure: children will participate in non-screen-based quiet activities
干预措施: Calming Content (Behavioral)
结局指标
主要结局
Differences in Subjective Sleep Quality on nights following the experimental and internal negative
时间窗: Night 9 and 16
Visual analog scales will be used to collect subjective ratings of sleep quality and morning alertness the morning following the study condition. Participants will be asked to rate the quality of their sleep last night (very poor to very good), how difficult was it for them to wake up this morning (very easy to very hard), and how alert do you feel right now (wide awake to very sleepy).
Differences in Sleep Duration on nights following the experimental and internal negative control exposures
时间窗: Night 9 and 16
Children will wear an Actiwatch Spectrum watch (Philips Respironics, Inc.) on the wrist of their non-dominant hand. Total sleep time are the total minute of sleep scored as sleep by the Sadeh algorithm between sleep onset and sleep offset.
次要结局
- Differences in ratings of subjective emotion regulation following the the experimental and internal negative exposures(Day 10 and 17)
- Differences in performance on the Letter Number Sequencing subtest of the WISC-V following the experimental and internal negative exposures(Day 10 and 17)
- Differences in Performance on the Delis-Kaplan Executive Function System The Color-Word Inference Test following the experimental and internal negative exposures(Day 10 and 17)
- Differences in Performance on the Delis-Kaplan Executive Function System The Sorting Test following the experimental and internal negative exposures(Day 10 and 17)
- Differences in performance on the Psychomotor Vigilance Task(Day 10 and 17)
- Differences in the change in circadian phase(night 8 to night 10 and night 15 to night 17)
- Differences in Sleep Latency on nights following the experimental and internal negative control exposures(Night 9 and 16)
- Differences in Heart Rate during the experimental and internal negative exposures(Night 9 and 16)
- Differences in Heart Rate Variability during the experimental and internal negative exposures(Night 9 and 16)
- Differences in Pre-sleep arousal scale following the the experimental and internal negative exposures(Night 9 and 16)
- Differences in Subjective Sleepiness during the experimental and internal negative exposures(Night 9 and 16)
- Differences in Performance on the Trier Social Stress Test following the the experimental and internal negative exposures(Day 10 and 17)
研究者
Jennette P. Moreno, PhD
Assistant Professor
Baylor College of Medicine