SCREENS: Sleep, Circadian Rhythms, and Electronics in the EveNing Study

NCT06192745 | Recruiting DMC

• 2 other identifiers: H-53533R01HD112349
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep; Circadian Rhythm; Executive Function; Emotion Regulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Night 9 and 16

Secondary Outcomes (12)

• 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

Other Outcomes (9)

• Ambient Light Exposure

  Days 1-17

• Average daily duration of Tablet use (excluding the experimental exposures)

  Days 1-17

• Other Screen Media Use

  Days 1-17

Study Arms (4)

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

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

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

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

Behavioral: no screen control with dim light and calming activities; Behavioral: Filtered dim tablet screen; Behavioral: Calming Content

Interventions

no screen control with dim light and calming activities BEHAVIORAL

Non-screen-based quiet activities for 1 hour before bed in room lighting 40-50 lux

Also known as: internal negative control

Group 1; Group 2; Group 3; Group 4

unfiltered Bright tablet screen BEHAVIORAL

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

Group 1; Group 2

Filtered dim tablet screen BEHAVIORAL

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

Group 3; Group 4

Exciting content BEHAVIORAL

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 1; Group 3

Calming Content BEHAVIORAL

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 2; Group 4

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Nutrition Research Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Jennette P Moreno, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Candice A Alfano, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Insia Raza, MPH

CONTACT

713-798-0555; insia.raza@bcm.edu

Hafza Dadabhoy

CONTACT

718-798-0557; dadabhoy@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators will be blinded to treatment condition in the analysis of outcomes
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 5, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available for a minimum of 3 years following the closeout of the grant, though data will be retained at Baylor College of Medicine for a minimum of 7 years following the close-out of the study.
• Access Criteria: Access to the data will be controlled by the repository.

Locations

US (1)