SCREENS: Sleep, Circadian Rhythms, and Electronics in the EveNing Study
NCT ID: NCT06192745
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2025-01-10
2028-08-30
Brief Summary
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Detailed Description
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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. A similar posture will be used in the control condition. 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. The next 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.
During the week prior to each weekend assessment, the procedures will be the same for all participants. Parents will select a bedtime and wake time for their child based on their habitual sleep times (+/- 30 mins). Families will be asked to maintain this sleep schedule for the duration of the 2-week protocol, except on nights when DLMO is assessed. Adherence to sleep/wake patterns will be assessed via actigraphy. Because previous exposure to light and screen media can impact future responsiveness to light and screen media, the research team will assess children's ambient light exposure using a reliable sensor clipped near the shirt collar. Mobile device screen use will be assessed using an app downloaded onto the tablet. Other types of screen media use will be assessed by parent report. Variables assessed during the weeks preceding the experimental weekend will be used as covariates in the analysis.
While 200 children are needed to be powered to examine the interaction effect of light and content on children's total sleep time, an additional 20 children will be recruited to account for attrition. The total sample size will be up 220 children.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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
no screen control with dim light and calming activities
Non-screen-based quiet activities for 1 hour before bed in room lighting 40-50 lux
unfiltered Bright tablet screen
Bright light screen media exposure will be delivered on an iPad Pro provided by the research team which will be set to the brightest light intensity setting for 1 hour before bed in room lighting 40-50 lux
Exciting content
We will create a 1-hour recording of movie clips containing exciting content from age-appropriate movies for 8- to 11-year-old children as rated by Common Sense Media.
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
no screen control with dim light and calming activities
Non-screen-based quiet activities for 1 hour before bed in room lighting 40-50 lux
unfiltered Bright tablet screen
Bright light screen media exposure will be delivered on an iPad Pro provided by the research team which will be set to the brightest light intensity setting for 1 hour before bed in room lighting 40-50 lux
Calming Content
We will create a 1-hour recording of movie clips containing calming content from age-appropriate movies for 8- to 11-year-old children as rated by Common Sense Media.
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
no screen control with dim light and calming activities
Non-screen-based quiet activities for 1 hour before bed in room lighting 40-50 lux
Filtered dim tablet screen
Filtered dim light screen media exposure will be delivered for 1 hour before bed in room lighting 40-50 lux on an iPad Pro provided by the research team. A blue light filter will be used to alter the spectral distribution of the emitted light and the screen brightness will be dimmed to the lowest possible setting
Exciting content
We will create a 1-hour recording of movie clips containing exciting content from age-appropriate movies for 8- to 11-year-old children as rated by Common Sense Media.
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
no screen control with dim light and calming activities
Non-screen-based quiet activities for 1 hour before bed in room lighting 40-50 lux
Filtered dim tablet screen
Filtered dim light screen media exposure will be delivered for 1 hour before bed in room lighting 40-50 lux on an iPad Pro provided by the research team. A blue light filter will be used to alter the spectral distribution of the emitted light and the screen brightness will be dimmed to the lowest possible setting
Calming Content
We will create a 1-hour recording of movie clips containing calming content from age-appropriate movies for 8- to 11-year-old children as rated by Common Sense Media.
Interventions
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no screen control with dim light and calming activities
Non-screen-based quiet activities for 1 hour before bed in room lighting 40-50 lux
unfiltered Bright tablet screen
Bright light screen media exposure will be delivered on an iPad Pro provided by the research team which will be set to the brightest light intensity setting for 1 hour before bed in room lighting 40-50 lux
Filtered dim tablet screen
Filtered dim light screen media exposure will be delivered for 1 hour before bed in room lighting 40-50 lux on an iPad Pro provided by the research team. A blue light filter will be used to alter the spectral distribution of the emitted light and the screen brightness will be dimmed to the lowest possible setting
Exciting content
We will create a 1-hour recording of movie clips containing exciting content from age-appropriate movies for 8- to 11-year-old children as rated by Common Sense Media.
Calming Content
We will create a 1-hour recording of movie clips containing calming content from age-appropriate movies for 8- to 11-year-old children as rated by Common Sense Media.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
8 Years
11 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Baylor College of Medicine
OTHER
Responsible Party
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Jennette P. Moreno, PhD
Assistant Professor
Principal Investigators
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Jennette P Moreno, PhD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Candice A Alfano, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Houston
Locations
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Children's Nutrition Research Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-53533
Identifier Type: -
Identifier Source: org_study_id
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