SleepNCT05820555

The Goodnight Screen Media Study

A study testing Timed evening technology and digital media use (tablet use) and no technology and digital media use (screen media use) in people with Sleep and Sleep Hygiene, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 48 to 59 monthsHealthy volunteers can take part
Conditions the study is for: Sleep, Sleep Hygiene
What is being tested?: Timed evening technology and digital media use (tablet use) and no technology and digital media use (screen media use)
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: 170 participants
Where: 1 siteUnited States
Study dates: 24 Apr 2023to 16 May 2026
Phase: Interventional
Are there results?: None posted in the registry

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 48 to 59 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Nutrition Research Center
Houston, Texas, 77030

Other trials in United States

About this study

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

Read the detailed 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).

Conditions: Sleep, Sleep Hygiene
Being tested: Timed evening technology and digital media use (tablet use), no technology and digital media use (screen media use)
Keywords: circadian phase, sleep, evening screen media use
Medical subject headings: Sleep Hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05820555
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: no technology and digital media use (screen media use)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Day 14 to Day 21

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14 to Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 202316 May 2026

First posted19 Apr 2023
Study start24 Apr 2023
Primary completion16 May 2026
Study completion16 May 2026

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
Model description: 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
Masking: Single blind
Who is masked: Investigator
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05820555
Sponsor's protocol ID: H-52269
Other IDs: P01 HD109876-01 5256, P01HD109876-01
Status last verified: Jun 2026
First submitted: 13 Feb 2023
Last updated: 5 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Experimental Effects of Children's Evening Media Use on Circadian Phase, Sleep and Executive Functioning
ClinicalTrials.gov ID: NCT05820555
Acronym / sponsor ID: H-52269
Conditions: Sleep, Sleep Hygiene
Keywords: circadian phase, sleep, evening screen media use
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Collaborators: William Marsh Rice University, University of Nevada, Reno, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 24 Apr 2023 (actual)
Primary completion: 16 May 2026 (actual)
Study completion: 16 May 2026 (actual)
First posted: 19 Apr 2023 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3
Model description: 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

Arm	Type	Receives
Group A: 1 hour of tablet use in the hour before bed	Experimental	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 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.
Group B: 1 hour of tablet use 2 hours before bed	Experimental	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.
Control Condition	Active comparator	Behavioral: no technology and digital media use (screen media 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.

Who may qualify

Ages: 48 to 59 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (2 listed)

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.

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

Primary outcome

Change in Dim light Melatonin Onset Phase
Time frame: Day 7 to Day 14
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.
Change in Dim light Melatonin Onset Phase
Time frame: Day 14 to Day 21
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.

9 secondary outcomes

Change in the Average Sleep Onset
Time frame: Day 1 through 6 to Day 9 through Day 13
Change in the Average Sleep Onset
Time frame: Day 9 through 13 and Day 16 through 20
Change in Average Sleep duration
Time frame: Day 1 through 6 to Day 9 through Day 13
Change in Average Sleep duration
Time frame: Day 9-13 and Day 16-20
Change in Inhibitory Control-Day/Night
Time frame: Day 14 or Day 21
Change in Inhibitory Control-Grass/Snow
Time frame: Day 14 or Day 21
Change in Working memory
Time frame: Day 14 to Day 21
Change in Working memory
Time frame: Day 14 to Day 21
Change in combined assessment of Executive Functioning working memory and inhibitory control
Time frame: Day 14 to Day 21

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Individual participant dataSharing planned: 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.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 2 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: finished, as of the sponsor's last update on 5 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Dim light Melatonin Onset Phase (time frame: Day 7 to Day 14). 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?

On the ClinicalTrials.gov record for NCT05820555.

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 5 Jun 2026.