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

January 3, 2024 updated by: Guanghai Wang, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nap rested and nap restriction
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voltage of N2 and Late Positive Potential (LPP) components
Time Frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
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
Time Frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive function - behavior
Time Frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
The Heart and Flower Paradigm is used to measure child executive function. The children are asked to press left button while seeing a heart in the middle of the screen, and to press the right button while seeing a flower in the middle of the screen. The correct rate and response time is used to compare the executive performance across sleep conditions.
20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
Executive function - EEG signal
Time Frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
The Heart and Flower Paradigm is used to measure child executive function. The children are asked to press left button while seeing a heart in the middle of the screen, and to press the right button while seeing a flower in the middle of the screen. And the EEG signal are collected simultaneously. The β/Θ ratio of EEG signal is used to compare executive brain functions across sleep conditions.
20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
Emotional arousal
Time Frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
During the Concern for Others Paradigm, the child's epidermal electricity level is measured at baseline and during the pain demonstration, and the differences between baseline and during the pain demonstration are used to compare the child's emotional arousal across sleep conditions.
20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
Emotion regulation
Time Frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
During the Concern for Others Paradigm, the child's respiratory sinus arrhythmia level is measured at baseline and during the pain demonstration, and the differences between baseline and during the pain demonstration are used to compare the child's emotion regulation across sleep conditions.
20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
Prosocial behavior level
Time Frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
After the Empathic for Pain Event-related Potential Paradigm and Heart and Flower Paradigm are finished. Prosocial behaviors are measured under the Concern for Others Paradigm. Children are introduced to a playroom, where the experimenter plays with the child and "accidentally" hurts herself. The experimenter then demonstrates pain for one minute under standard procedure. Children's behaviors and expressions are recorded, and coded in four aspects: prosocial behaviors (1 to 6 points, higher scores represent higher levels of prosocial behaviors); empathic concern (1 to 4 points, higher scores represent higher levels of empathic concern); hypothesis testing (1 to 4 points, higher scores represent higher levels of hypothesis testing); and avoidance (0 to 1 points, higher scores represent higher levels of avoidance).
20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Fan Jiang, PhD, Shanghai Children's Medical Center
  • Principal Investigator: Guanghai Wang, PhD, Shanghai Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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