The Goodnight Screen Media Study

Sleep Clinical Trial

Official title:

Experimental Effects of Children's Evening Media Use on Circadian Phase, Sleep and Executive Functioning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820555
• Other study ID #: H-52269
• Secondary ID: P01 HD109876-01
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: Baylor College of Medicine
• Contact: Jennifer Coon
• Phone: 713-798-7143
• Email: coon[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 31, 2026
• Est. primary completion date: May 28, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 48 Months to 59 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Sleep
• Sleep Hygiene

Intervention

Behavioral:
• Timed evening technology and digital media use (tablet use)
timing of children's evening tablet device use relative to bedtime
• no technology and digital media use (screen media use)
no screen media use relative to bedtime (Tablets, computers, TV, moble devices, smart phone)

Locations

Country	Name	City	State
United States	Children's Nutrition Research Center	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Baylor College of Medicine	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Northern Illinois University, William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ambient Light Exposure	ActLumus devices containing a photocell will be used to assess ambient light exposure. Devices will be pinned to the shirt. ActLumus devices are capable of assessing light intensity and wavelength. Light exposure will be used as a covariate in analyses.	Days 1-21
Other	Average daily duration of Tablet use (excluding the experimental exposures)	Children's tablet use on Android and iOS devices will be assessed during the study period. Daily screen use will be used as a covariate in the analysis. The Chronicle app will be used to assess the timing and amount of children's Android device use. Code developed by Arcascope will be used to assess the amount of children's iOS device usage.	Days 1-21
Other	Percentage of time that children followed the screen media use guidelines for their condition during week 2	The Chronicle and Acrascope data will be used to assess adherence to the evening tablet use conditions.	Days 8-13
Other	Percentage of time that children followed the screen media use guidelines for their condition during week 3	The Chronicle and Acrascope data will be used to assess adherence to the evening tablet use conditions.	Days 15-20
Other	Children's Sleep Hygiene Scale (total score)	Sleep hygiene will be assessed by parent report on the Children's Sleep Hygiene Scale. Contains 22 items. Response options are scored as follows: Never (1 point); Once in Awhile (2 points); Sometimes (3 points); Quite Often (4 points); Frequently, if not Always (5 points); Always (6 points). It contains 6 subscales that are computed by computing the mean of the items (each subscale could range from 1-6). The total score is computed by computing the mean of the subscales, with a potential range of 1-6. The total score will be used as the outcome of interest in the current study. Higher scores indicate better sleep hygiene practices.	Day 7
Other	The Children's Chronotype Questionnaire	Chronotype will be assessed by parent report of the child's preference for morningness or eveningness. The M/E score is calculated by adding items 17-26 (responses scored as a=1, b=2, c=3, d=4, d=5), except items 17,18,24,25 are reverse scored. the M/E score ranges from 10 (extreme morningness) to 49 (extreme eveningness). Morning types are defined as having a M/E scale score of =23, intermediate types: score of 24-32, and evening types: score =33.	Day 7
Other	Children's Sleep Habits Questionnaire	Parents will be asked to report children's sleep behaviors and problems on the Child Sleep Habits Questionnaire. The total sleep disturbance score is comprised of 33 items. Response options are scored as Usually = 3; Sometimes = 2; and Never/Rarely = 1. Scores range from 33 to 99. Higher scores indicate more sleep problems.	Day 7
Primary	Change in Dim light Melatonin Onset Phase	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.	Day 7 to Day 14
Primary	Change in Dim light Melatonin Onset Phase	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.	Day 14 to Day 21
Secondary	Change in the Average Sleep Onset	Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the non dominant hand 24 hours a day for 4-5 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off.	Day 1 through 6 to Day 9 through Day 13
Secondary	Change in the Average Sleep Onset	Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the non dominant hand 24 hours a day for 4-5 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off.	Day 9 through 13 and Day 16 through 20
Secondary	Change in Average Sleep duration	Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the non dominant hand 24 hours a day for 4-5 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off.	Day 1 through 6 to Day 9 through Day 13
Secondary	Change in Average Sleep duration	Actigraphs (GT3X-BT, Pensacola, FL) worn on the wrist of the non dominant hand 24 hours a day for 4-5 days will measure sleep duration and timing of sleep onset and waking. Wrist placement reliably measures sleep duration. Sleep diaries will be completed. Monitor-wear logs will identify times the accelerometer is removed and the activity engaged in while the monitor is off.	Day 9-13 and Day 16-20
Secondary	Change in Inhibitory Control-Day/Night	Children's inhibitory control will be assessed using the Day/Night task. The order of this task will be counterbalanced across Day 14 and 21. This task can be used interchangeably with Grass/snow, so we will examine the difference in performance from the test administered on day 14 to the test administered on day 21.	Day 14 or Day 21
Secondary	Change in Inhibitory Control-Grass/Snow	Children's inhibitory control will be assessed using the Grass/Snow. The order of this task will be counterbalanced across Day 14 and 21. This task can be used interchangeably with Grass/snow, so we will examine the difference in performance from the test administered on day 14 to the test administered on day 21.	Day 14 or Day 21
Secondary	Change in Working memory	Children's Working Memory will be assessed using the Missing Scan assessment. This task will be administered at Day 14 and 21.	Day 14 to Day 21
Secondary	Change in Working memory	Children's Working Memory will be assessed using the Spin the Pots assessment. This task will be administered at Day 14 and 21.	Day 14 to Day 21
Secondary	Change in combined assessment of Executive Functioning working memory and inhibitory control	The Head-Toes-Knees-Shoulder Task assesses both working memory and inhibitory control and will be administered on Day 14 and Day 21.	Day 14 to Day 21