SleepSCREENSNCT06192745
SCREENS: Sleep, Circadian Rhythms, and Electronics in the EveNing Study
A study testing unfiltered Bright tablet screen, Filtered dim tablet screen and Exciting content in people with Sleep and Circadian Rhythm, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Circadian Rhythm, Executive Function
- What is being tested?
- unfiltered Bright tablet screen, Filtered dim tablet screen and Exciting content
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2025to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Nutrition Research Center
Houston, Texas, 77030
Insia Raza, MPH, 713-798-0555, insia.raza@bcm.edu
Hafza Dadabhoy, MS RD LD, 713-798-0557, dadabhoy@bcm.edu
About this study
Official title: Experimental Effects of Light And Content From Evening Screen Media Use On Children's Sleep, Executive Functioning, And Emotion Regulation
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.
Read the detailed description
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.
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
- Sleep, Circadian Rhythm, Executive Function, Emotion Regulation
- Being tested
- no screen control with dim light and calming activities, unfiltered Bright tablet screen, Filtered dim tablet screen, Exciting content, Calming Content
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no screen control with dim light and calming activitiesBehavioural
Also called internal negative control
Non-screen-based quiet activities for 1 hour before bed in room lighting 40-50 lux
unfiltered Bright tablet screenBehavioural
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 screenBehavioural
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 contentBehavioural
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 ContentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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 Receives: Behavioral: no screen control with dim light and calming activities; Behavioral: unfiltered Bright tablet screen; Behavioral: Exciting content |
| Group 2 | Experimental | 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 Receives: Behavioral: no screen control with dim light and calming activities; Behavioral: unfiltered Bright tablet screen; Behavioral: Calming Content |
| Group 3 | Experimental | 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 Receives: Behavioral: no screen control with dim light and calming activities; Behavioral: Filtered dim tablet screen; Behavioral: Exciting content |
| Group 4 | Experimental | 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 Receives: Behavioral: no screen control with dim light and calming activities; Behavioral: Filtered dim tablet screen; Behavioral: Calming Content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Sleep Duration on nights following the experimental and internal negative control exposures
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.
Measured: Night 9 and 16
Differences in Subjective Sleep Quality on nights following the experimental and internal negative
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).
Measured: Night 9 and 16
Secondary outcomes (11)
Differences in the change in circadian phase
Circadian phase can be examined by measuring the circadian timing of melatonin onset under dim light conditions (dim light melatonin onset; DMLO). Following established procedures with children, salivary DLMO will be collected 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. We will examine differences in the change from night 8 to night 10 and the change from night 15 to night 17.
Measured: 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
Children will wear an Actiwatch Spectrum watch (Philips Respironics, Inc.) on the wrist of their non-dominant hand. Sleep latency (i.e., the time between when they child starts to try to fall asleep as indicated by a push of the event marker button on the Actiwatch and when the child falls asleep (first 3 consecutive epochs of sleep).
Measured: Night 9 and 16
Differences in Heart Rate during the experimental and internal negative exposures
Heart rate (HR) will be assessed using a Polar H10 HR monitor which integrates with the Actigraph GT3X-BT devices to record HR data from which raw data can be extracted. The Polar H10 HR monitor will be worn on a chest strap fitted to the child according to manufacturer guidelines during the 1-hour experimental and internal negative exposures.
Measured: Night 9 and 16
Differences in Heart Rate Variability during the experimental and internal negative exposures
Heart rate variability (HRV) will be assessed using a Polar H10 HR monitor which integrates with the Actigraph GT3X-BT devices to record HR data from which raw data can be extracted. The Polar H10 HR monitor will be worn on a chest strap fitted to the child according to manufacturer guidelines during the 1-hour experimental and internal negative exposures.
Measured: Night 9 and 16
Differences in Pre-sleep arousal scale following the the experimental and internal negative exposures
the Pre-Sleep Arousal Scale for Children (PSAS-C) will be used to assess Children's subjective report of arousal prior to sleep on Night 2. The PSAS-C contains 16 items comprising 2 subscales assessing somatic and cognitive arousal and demonstrated high internal consistency. Items are scored on a Likert scale from 1 to 5 with scores ranging from 16 to 80. Higher scores indicate greater pre-sleep arousal.
Measured: Night 9 and 16
Differences in Subjective Sleepiness during the experimental and internal negative exposures
The Pictorial Sleepiness Scale is a measure of perceived sleepiness in a given moment that has been validated with individuals 4- to 73-years of age, demonstrating a strong correlation with the Karolinska Sleepiness Scale (r=.72) and the Sandford Sleepiness Scale(r=.94). The use of cartoon faces facilitates the assessment of sleepiness in population with minimal literacy skills. Almost all participants (99%) correctly ranked the faces in order of sleepiness. Children will complete the sleepiness scale before the start of the experimental condition (~60 minute prior to bedtime), 30 minutes later, and again at bedtime.
Measured: Night 9 and 16
Differences in Performance on the Trier Social Stress Test following the the experimental and internal negative exposures
To assess objective emotion regulation in the home on Day 3, we will use a modified version the Trier Social Stress Test (TSST), The task will begin with a 5-min baseline segment, during which children will be asked to relax while they listen to a recording of nature sounds (i.e., waves at the beach) in order to collect resting HR and HRV). After this baseline period, children will then engage in a task in which they To assess objective emotion regulation in the home on Day 3, we will use a modified version the Trier Social Stress Test (TSST), The task will begin with a 5- min baseline segment, during which children will be asked to relax while they listen to a recording of nature sounds (i.e., waves at the beach) in order to collect resting HR and HRV). After this baseline period, children will then engage in a task in which they imagine they are giving a speech in front of a class of 20 kids they have never met. Resting and task-based HR and HRV data will be collected.
Measured: Day 10 and 17
Differences in ratings of subjective emotion regulation following the the experimental and internal negative exposures
Subjective reports of emotional arousal and regulation will also be collected before and after the 5-minute speech task. Children will provide ratings of arousal using the Self-Assessment Manikin (SAM), a widely-used non-verbal pictorial scale that measures arousal associated with a person's affective reaction to a wide variety of situations and stimuli. Emotion regulation will be assessed via a likert-type rating requiring children to indicate how difficult it was to regulate (control) their emotions during the speech task, from ) (not hard at all) to 10 (very hard).
Measured: Day 10 and 17
Differences in performance on the Letter Number Sequencing subtest of the WISC-V following the experimental and internal negative exposures
Letter-number sequencing Test (WISC-V) asks children to listen to lists of letters and digits and repeat the letters back in alphabetical order, and the digits in ascending numerical order, with the lists increasing in length from 2-8 alphanumeric characters throughout the test. Children will be read three different alphanumeric series for each list lengths, and one point will be awarded for each correct recall, for a total of 21 points. This performance score will be used as a measure of working memory.
Measured: 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
The Color-Word Interference Test (D-KEFS) is a standard "Stroop-like" task. Across the two tasks, inhibition and inhibition switching, completion time and errors (4 indicators in total) are used as markers of inhibitory control. The inhibition task is a standard "Stroop-like" task. During inhibition switching, participants also encounter words in colored ink wherein they say the color and inhibit reading the work. However, during some trials, words are enclosed by a box wherein the participant needs to switch to reading, not naming, the color in which it is printed.
Measured: Day 10 and 17
Differences in performance on the Psychomotor Vigilance Task
Assesses vigilant attention (reaction time to changes in visual stimuli) and is sensitive to changes in sleep.
Measured: Day 10 and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Jan 2025
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jennette P. Moreno, PhD, Baylor College of Medicine
- Investigators
- Jennette P Moreno, PhD, Principal investigator, Baylor College of MedicineCandice A Alfano, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192745
- Sponsor's protocol ID
- H-53533
- Other IDs
- R01HD112349
- Acronym
- SCREENS
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be deposited in the National Institute of Child Health and Human Development-maintained Data and Specimen Hub (DASH) data repository.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Effects of Light And Content From Evening Screen Media Use On Children's Sleep, Executive Functioning, And Emotion Regulation
- ClinicalTrials.gov ID
- NCT06192745
- Acronym / sponsor ID
- SCREENS / H-53533
- Conditions
- Sleep, Circadian Rhythm, Executive Function, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: no screen control with dim light and calming activities, Behavioral: unfiltered Bright tablet screen, Behavioral: Exciting contentChildren 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 |
| Group 2 | Experimental | Behavioral: no screen control with dim light and calming activities, Behavioral: unfiltered Bright tablet screen, Behavioral: Calming ContentChildren 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 |
| Group 3 | Experimental | Behavioral: no screen control with dim light and calming activities, Behavioral: Filtered dim tablet screen, Behavioral: Exciting contentChildren 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 |
| Group 4 | Experimental | Behavioral: no screen control with dim light and calming activities, Behavioral: Filtered dim tablet screen, Behavioral: Calming ContentChildren 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 |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no screen control with dim light and calming activitiesAlso: internal negative controlNon-screen-based quiet activities for 1 hour before bed in room lighting 40-50 lux | Behavioural | Group 1, Group 2, Group 3, Group 4 |
| unfiltered Bright tablet screenBright 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 | Behavioural | Group 1, Group 2 |
| Filtered dim tablet screenFiltered 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 | Behavioural | Group 3, Group 4 |
| Exciting contentWe 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. | Behavioural | Group 1, Group 3 |
| Calming ContentWe 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. | Behavioural | Group 2, Group 4 |
Primary outcome
Differences in Sleep Duration on nights following the experimental and internal negative control exposures
Time frame: 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.
Differences in Subjective Sleep Quality on nights following the experimental and internal negative
Time frame: 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).
11 secondary outcomes
Differences in the change in circadian phase
Time frame: 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
Time frame: Night 9 and 16
Differences in Heart Rate during the experimental and internal negative exposures
Time frame: Night 9 and 16
Differences in Heart Rate Variability during the experimental and internal negative exposures
Time frame: Night 9 and 16
Differences in Pre-sleep arousal scale following the the experimental and internal negative exposures
Time frame: Night 9 and 16
Differences in Subjective Sleepiness during the experimental and internal negative exposures
Time frame: Night 9 and 16
Differences in Performance on the Trier Social Stress Test following the the experimental and internal negative exposures
Time frame: Day 10 and 17
Differences in ratings of subjective emotion regulation following the the experimental and internal negative exposures
Time frame: Day 10 and 17
Differences in performance on the Letter Number Sequencing subtest of the WISC-V following the experimental and internal negative exposures
Time frame: 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
Time frame: Day 10 and 17
Differences in performance on the Psychomotor Vigilance Task
Time frame: Day 10 and 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. Data will be deposited in the National Institute of Child Health and Human Development-maintained Data and Specimen Hub (DASH) data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennette P Moreno, PhD principal investigator
Baylor College of Medicine
Candice A Alfano, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unfiltered Bright tablet screen, Filtered dim tablet screen and Exciting content in people with Sleep and Circadian Rhythm, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insia Raza, MPH (713-798-0555, insia.raza@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Sleep Duration on nights following the experimental and internal negative control exposures (time frame: Night 9 and 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.