The Goodnight Screen Media Study

NCT05820555 | Recruiting DMC

• 3 other identifiers: H-52269P01 HD109876-01 5256P01HD109876-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep; Sleep Hygiene

Keywords

circadian phase; sleep; evening screen media use

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Change in the Average Sleep Onset

  Day 1 through 6 to Day 9 through Day 13

• Change in the Average Sleep Onset

  Day 9 through 13 and Day 16 through 20

• Change in Average Sleep duration

  Day 1 through 6 to Day 9 through Day 13

• Change in Average Sleep duration

  Day 9-13 and Day 16-20

• Change in Inhibitory Control-Day/Night

  Day 14 or Day 21

Other Outcomes (7)

• Ambient Light Exposure

  Days 1-21

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

  Days 1-21

• Percentage of time that children followed the screen media use guidelines for their condition during week 2

  Days 8-13

Study Arms (3)

Group A: 1 hour of tablet use in the hour before bed

EXPERIMENTAL

During week 1, children will maintain a sleep schedule within 30 minutes +/- of their habitual bedtime. This bedtime will be maintained throughout the 3 weeks of the study except on nights when dim light melatonin onset is assessed in the lab. During week 2, participants will be asked to reframe from screen use in the 3 hours before bed time for 6 evenings. During week 3, participants will be exposed to 1 hour of tablet use (Standard bright setting), 1 hour before bedtime for 6 evenings.

Behavioral: Timed evening technology and digital media use (tablet use)

Group B: 1 hour of tablet use 2 hours before bed

EXPERIMENTAL

During week 1, children will maintain a sleep schedule within 30 minutes +/- of their habitual bedtime. This bedtime will be maintained throughout the 3 weeks of the study except on nights when dim light melatonin onset is assessed in the lab. During week 2, participants will be asked to reframe from screen use in the 3 hours before bedtime for 6 evenings. During week 3, participants will be exposed to 1 hour of tablet use (Standard bright setting), 2 hours before bedtime (and no screen use in the hour before bed) for 6 evenings.

Behavioral: Timed evening technology and digital media use (tablet use)

Control Condition

ACTIVE COMPARATOR

During week 1, children will maintain a sleep schedule within 30 minutes +/- of their habitual bedtime. This bedtime will be maintained throughout the 3 weeks of the study except on nights when dim light melatonin onset is assessed in the lab. During week 2, participants will engage no screen use for the 3 hours before bedtime for 6 evenings. During week 3, participants will be asked to engage in no screen use in the 3 hours before bedtime for 6 evenings.

Behavioral: no technology and digital media use (screen media use)

Interventions

Timed evening technology and digital media use (tablet use) BEHAVIORAL

timing of children's evening tablet device use relative to bedtime

Group A: 1 hour of tablet use in the hour before bed; Group B: 1 hour of tablet use 2 hours before bed

no technology and digital media use (screen media use) BEHAVIORAL

no screen media use relative to bedtime (Tablets, computers, TV, moble devices, smart phone)

Control Condition

Eligibility Criteria

• Age: 48 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• William Marsh Rice University: collaborator
• University of Nevada, Reno: collaborator

Study Sites (1)

Children's Nutrition Research Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Sleep Hygiene

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Jennifer Coon

CONTACT

713-798-7143; coon@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blinding of the study biostatistician and PI during the analysis will be ensured. Groups will be denoted by a variable that does not reveal its identity. The blinding will be broken after the data set is closed and analyses completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatrics - Nutrition

Model Details: A 3-group randomized controlled trial design will be used in which children are assigned to receive one of 2 experimental conditions or a control condition

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: April 19, 2023
• Study Start: April 24, 2023
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: All de-identified scientific data generated by the study, and any necessary metadata (including, but not limited to, study protocols and documentation on data collection instruments), will be deposited in the NICHD-maintained Data and Specimen Hub (DASH) data repository no later than at the time of acceptance for an associated publication, or at the end of funding period, whichever is sooner. Code will be shared via the Rice team's webpage at https://computationalimaging.rice.edu/code/ or via GitHub
• Access Criteria: Users of the DASH repository must agree to the DASH user agreement

Locations

US (1)