An interventional study of Timed evening technology and digital media use (tablet use) and no technology and digital media use (screen media use) in Sleep and Sleep Hygiene, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 48 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Prevention
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.
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).
126 studies on the registry are indexed under Sleep Hygiene; 32 are open to participants now.
This study's enrollment of 170 is above the median of 66 across 113 interventional studies indexed under Sleep Hygiene.
Browse Sleep Hygiene studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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)
timing of children's evening tablet device use relative to bedtime
no screen media use relative to bedtime (Tablets, computers, TV, moble devices, smart phone)
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.
Time frame: 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.
Time frame: Day 14 to Day 21
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.
Time frame: Day 1 through 6 to Day 9 through Day 13
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.
Time frame: Day 9 through 13 and Day 16 through 20
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.
Time frame: Day 1 through 6 to Day 9 through Day 13
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.
Time frame: Day 9-13 and Day 16-20
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.
Time frame: Day 14 or Day 21
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.
Time frame: Day 14 or Day 21
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.
Time frame: Day 14 to Day 21
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.
Time frame: Day 14 to Day 21
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.
Time frame: Day 14 to Day 21
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.
Time frame: Days 1-21
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.
Time frame: Days 1-21
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.
Time frame: Days 8-13
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.
Time frame: Days 15-20
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.
Time frame: Day 7
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.
Time frame: Day 7
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.
Time frame: Day 7
Plan to share: Yes — The principal investigator and co-investigators acknowledge their willingness to share data with other eligible investigators through academically established means. Summarized data will be shared with collaborators as soon as available, with local colleagues at seminars and talks, and with the scientific community at large by posters and presentations at local, regional, national and international scientific meetings. Individual participant data may be shared in accordance with the NIH data sharing policy.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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
Data sharing details ↗ · dash.nichd.nih.gov
No publications or documents are linked to this record.
Ran from Apr 2023 to primary completion in May 2026, 36 months.
Of 75 non-industry interventional studies with no phase under Sleep Hygiene, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 36 months is above that.
Counting every sponsor, half of 79 studies reached it within 8 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.