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Behavioural Intervention
Evening Screen Time for Sleep Issues in Kids
N/A
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 9 through 13 and day 16 through 20
Awards & highlights
No Placebo-Only Group
Summary
This trial examines effects of evening tablet use on kids' sleep, behavior, and cognitive abilities.
Who is the study for?
This study is for preschool-aged children (4 to just under 5 years old) and their parents in the Greater Houston area. Parents must be primary caregivers, comfortable with English, and have a child who uses or has access to an Android OS ≥5.0 or Apple iOS ≥14.0 tablet.
What is being tested?
The study examines how using tablets in the evening affects young children's sleep patterns and behavior compared to not using screen media at all. It looks into when kids fall asleep, how long they sleep, and their ability to control impulses.
What are the potential side effects?
Since this trial involves technology use rather than medication, traditional side effects are not applicable. However, potential impacts may include changes in sleep quality or duration as well as alterations in mood or behavior.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 9 through 13 and day 16 through 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 9 through 13 and day 16 through 20
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Dim light Melatonin Onset Phase
Secondary study objectives
Change in Average Sleep duration
Change in Inhibitory Control-Day/Night
Change in Inhibitory Control-Grass/Snow
+3 moreOther study objectives
Ambient Light Exposure
Average daily duration of Tablet use (excluding the experimental exposures)
Children's Sleep Habits Questionnaire
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Group B: 1 hour of tablet use 2 hours before bedExperimental Treatment1 Intervention
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.
Group II: Group A: 1 hour of tablet use in the hour before bedExperimental Treatment1 Intervention
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 III: Control ConditionActive Control1 Intervention
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.
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Who is running the clinical trial?
Northern Illinois UniversityOTHER
8 Previous Clinical Trials
761 Total Patients Enrolled
William Marsh Rice UniversityOTHER
47 Previous Clinical Trials
27,957 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,299 Total Patients Enrolled
2 Trials studying Sleep
310 Patients Enrolled for Sleep
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 4 and 5 years old and we live in the Greater Houston area.I am comfortable with English and participating in the study.My child has a condition or takes medication that affects their sleep or learning abilities.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: 1 hour of tablet use in the hour before bed
- Group 2: Group B: 1 hour of tablet use 2 hours before bed
- Group 3: Control Condition
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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