Effects of Nap Restriction on Preschoolers' Empathy, Prosocial Behaviors and Executive Function

NCT06025669 | Completed

• 1 other identifier: SCMCIRB-K2022122-2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Restriction

Keywords

nap restriction; preschooler; socio-emotional development; executive function; event-related potential

Outcome Measures

Primary Outcomes (2)

• Voltage of N2 and Late Positive Potential (LPP) components

  Child brain electroencephalogram (EEG) signals were collected via a non-invasive electrical brain cap and a wireless signal amplifier during the Empathic for Pain Event-related Potential Paradigm. The paradigm presents 32 pairs of empathic pain-related pictures at each sleep intervention condition (e.g., a hand hit by a hammer). The children are asked to think about "How painful do you think the person in the picture feels?" while looking at each picture. After data processing, the voltages of N2 (i.e. the negative potential at approximately 200 ms poststimulus) and LPP (a protracted slow-wave component elicited by emotional stimuli) are output and compared across sleep conditions.

  20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction

• Empathic pain rating

  The Empathic for Pain Event-related Potential Paradigm presents 32 pairs of empathic pain-related pictures at each sleep intervention condition (e.g., a hand hit by a hammer). The children are asked to rate on "How pain do you think the person in the picture feels?" with the Wong-Baker FACES Pain Rating System. The Wong-Baker FACES Pain Rating System includes 6 faces demonstrating painful expressions, scoring 0, 2, 4, 6, 8, and 10 points respectively, with higher scores representing higher levels of vicarious painful feelings. The mean scores of ratings are used to compare the empathy behavioral level across sleep conditions.

  20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction

Secondary Outcomes (5)

• Executive function - behavior

  20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction

• Executive function - EEG signal

  20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction

• Emotional arousal

  20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction

• Emotion regulation

  20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction

• Prosocial behavior level

  20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction

Study Arms (1)

Nap rested and nap restriction

EXPERIMENTAL

There are two conditions in the single-arm, that is, the nap rested condition and the nap restriction condition. The sequence of two conditions is randomized.

Behavioral: Nap restriction

Interventions

Nap restriction BEHAVIORAL

There are 2 interventions in the single-arm, that is, the nap rested condition and the nap restriction condition. The sequence of nap intervention followed randomization.

Nap rested and nap restriction

Eligibility Criteria

• Age: 42 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• not able to fall asleep alone;
• travel beyond two time zones within 3 months of the study;
• 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;
• a first-degree family history of diagnosed narcolepsy, psychosis or bipolar disorder.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Location

Related Publications (6)

• 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.

  PMID: 25394169 BACKGROUND

• 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.

  PMID: 34904310 BACKGROUND

• 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.

  PMID: 28523733 BACKGROUND

• 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.

  PMID: 21600660 BACKGROUND

• 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.

  PMID: 31894624 BACKGROUND

• 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.

  PMID: 21988087 BACKGROUND

Study Officials

• Fan Jiang, PhD

  Shanghai Children's Medical Center

  STUDY DIRECTOR

• Guanghai Wang, PhD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Developing Brain Lab

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: September 6, 2023
• Study Start: September 6, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

CN (1)