Effects of Nap Restriction on Preschoolers' Empathy, Prosocial Behaviors and Executive Function (NCT06025669) | Clinical Trial Compass
CompletedNot Applicable
Effects of Nap Restriction on Preschoolers' Empathy, Prosocial Behaviors and Executive Function
China25 participantsStarted 2023-09-06
Plain-language summary
Cross-sectional evidences suggest a relationship between early childhood sleep and cognitive as well as socio-emotional functions. However, the casual relation has not been fully revealed. The current study aims to perform a randomized lab-based crossover nap restriction study on preschoolers, to determine the effects of sleep restriction on preschoolers empathy, prosocial behaviors as well as executive functions.
Who can participate
Age range
42 Months – 72 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. healthy, typically developing, Intelligence quotient (IQ) ≥ 85;
. never diagnosed with emotional-behavioral problems;
. sleeping on a regular daily schedule;
. reported napping three or more times every week, ≤ one nap in one day;
. able to fall asleep by themselves.
Exclusion criteria
. not able to fall asleep alone;
. travel beyond two time zones within 3 months of the study;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Voltage of N2 and Late Positive Potential (LPP) components
Timeframe: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
2
Empathic pain rating
Timeframe: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
Trial details
NCT IDNCT06025669
SponsorShanghai Jiao Tong University School of Medicine
. use of medications influencing sleep or alertness;
. reported or diagnosed sleep problems (such as obstructive sleep apnea (OSA), narcolepsy, parasomnia, insomnia, etc.) ;
. history of neurodevelopmental diseases, including developmental delay, epilepsy, chronic medical conditions, lead poisoning and head injuries involving loss of consciousness;
. conceptual age \<35 weeks or \> 45 weeks;
. birth weight \< 2,500 grams;
. Children's Behaviors Checklist (CBCL) total score \> 70;