Clinical trial NCT06025669: Effects of Nap Restriction on Preschoolers' Empathy, Prosocial Behaviors and Executive Function
Official title: Effects of Nap Restriction on Preschoolers' Empathy, Prosocial Behaviors and Executive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Restriction
Keywords: nap restriction
preschooler
socio-emotional development
executive function
event-related potential
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 25
Sex: ALL
Minimum age (years): 42
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: The study will enroll preschoolers with regular nap habits. Under a randomized repeated-measures crossover design, they follow a strict sleep schedule (≥ 12.5 hours' time in bed every 24 hours) for 5 days, before each of two pseudorandomly assigned afternoon assessments following nap-rested or nap-restricted conditions. Actigraphy is applied to monitor sleep, and occipital alpha power is detected from resting-state EEG to objectively measure sleepiness. Empathy (Empathic for Pain Event-related Potential Paradigm) and prosocial behaviors (Concern for Others Behavioral Paradigm) were measured at each assessment. The effects of nap restriction were analyzed with paired t-test/Wilcoxon matched-pairs sign rank test and repeated-measures ANOVA.

Eligibility criteria: Inclusion Criteria:

1. healthy, typically developing, Intelligence quotient (IQ) ≥ 85;
2. never diagnosed with emotional-behavioral problems;
3. sleeping on a regular daily schedule;
4. reported napping three or more times every week, ≤ one nap in one day;
5. able to fall asleep by themselves.

Exclusion Criteria:

1. not able to fall asleep alone;
2. travel beyond two time zones within 3 months of the study;
3. use of medications influencing sleep or alertness;
4. reported or diagnosed sleep problems (such as obstructive sleep apnea (OSA), narcolepsy, parasomnia, insomnia, etc.) ;
5. history of neurodevelopmental diseases, including developmental delay, epilepsy, chronic medical conditions, lead poisoning and head injuries involving loss of consciousness;
6. conceptual age \<35 weeks or \> 45 weeks;
7. birth weight \< 2,500 grams;
8. Children's Behaviors Checklist (CBCL) total score \> 70;
9. a first-degree family history of diagnosed narcolepsy, psychosis or bipolar disorder.

Primary outcomes:
measure: Voltage of N2 and Late Positive Potential (LPP) components
timeFrame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
measure: Empathic pain rating
timeFrame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
Secondary outcomes:
measure: Executive function - behavior
timeFrame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
measure: Executive function - EEG signal
timeFrame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
measure: Emotional arousal
timeFrame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
measure: Emotion regulation
timeFrame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
measure: Prosocial behavior level
timeFrame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Fan Jiang, PhD
role: STUDY_DIRECTOR
affiliation: Shanghai Children's Medical Center
name: Guanghai Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller AL, Seifer R, Crossin R, Lebourgeois MK. Toddler's self-regulation strategies in a challenge context are nap-dependent. J Sleep Res. 2015 Jun;24(3):279-87. doi: 10.1111/jsr.12260. Epub 2014 Nov 13.
citation: Rong T, Sun X, Zhang Z, Li W, Deng Y, Wang Z, Meng M, Zhu Q, Jiang Y, Zhao J, Zhang Y, Wang G, Jiang F. The association between sleep and empathy in young preschoolers: A population study. J Sleep Res. 2022 Aug;31(4):e13530. doi: 10.1111/jsr.13530. Epub 2021 Dec 13.
citation: Decety J, Meidenbauer KL, Cowell JM. The development of cognitive empathy and concern in preschool children: A behavioral neuroscience investigation. Dev Sci. 2018 May;21(3):e12570. doi: 10.1111/desc.12570. Epub 2017 May 18.
citation: Roth-Hanania R, Davidov M, Zahn-Waxler C. Empathy development from 8 to 16 months: early signs of concern for others. Infant Behav Dev. 2011 Jun;34(3):447-58. doi: 10.1016/j.infbeh.2011.04.007. Epub 2011 May 20.
citation: Adam N, Blaye A, Gulbinaite R, Delorme A, Farrer C. The role of midfrontal theta oscillations across the development of cognitive control in preschoolers and school-age children. Dev Sci. 2020 Sep;23(5):e12936. doi: 10.1111/desc.12936. Epub 2020 Feb 12.
citation: Berger RH, Miller AL, Seifer R, Cares SR, LeBourgeois MK. Acute sleep restriction effects on emotion responses in 30- to 36-month-old children. J Sleep Res. 2012 Jun;21(3):235-46. doi: 10.1111/j.1365-2869.2011.00962.x. Epub 2011 Oct 11.