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临床试验/NCT06025669
NCT06025669已完成不适用

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

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Voltage of N2 and Late Positive Potential (LPP) components

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
42 Months 至 72 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Voltage of N2 and Late Positive Potential (LPP) components

时间窗: 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.

Empathic pain rating

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guanghai Wang

Developing Brain Lab

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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