xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06025669</url>
    </required_header>
    <id_info>
      <org_study_id>SCMCIRB-K2022122-2</org_study_id>
      <nct_id>NCT06025669</nct_id>
    </id_info>
    <brief_title>Effects of Nap Restriction on Preschoolers' Empathy, Prosocial Behaviors and Executive Function</brief_title>
    <official_title>Effects of Nap Restriction on Preschoolers' Empathy, Prosocial Behaviors and Executive Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Jiao Tong University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Jiao Tong University School of Medicine</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cross-sectional evidences suggest a relationship between early childhood sleep and cognitive&#xD;
        as well as socio-emotional functions. However, the casual relation has not been fully&#xD;
        revealed. The current study aims to perform a randomized lab-based crossover nap restriction&#xD;
        study on preschoolers, to determine the effects of sleep restriction on preschoolers empathy,&#xD;
        prosocial behaviors as well as executive functions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will enroll preschoolers with regular nap habits. Under a randomized&#xD;
        repeated-measures crossover design, they follow a strict sleep schedule (≥ 12.5 hours' time&#xD;
        in bed every 24 hours) for 5 days, before each of two pseudorandomly assigned afternoon&#xD;
        assessments following nap-rested or nap-restricted conditions. Actigraphy is applied to&#xD;
        monitor sleep, and occipital alpha power is detected from resting-state EEG to objectively&#xD;
        measure sleepiness. Empathy (Empathic for Pain Event-related Potential Paradigm) and&#xD;
        prosocial behaviors (Concern for Others Behavioral Paradigm) were measured at each&#xD;
        assessment. The effects of nap restriction were analyzed with paired t-test/Wilcoxon&#xD;
        matched-pairs sign rank test and repeated-measures ANOVA.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 6, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Voltage of N2 and Late Positive Potential (LPP) components</measure>
      <time_frame>20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction</time_frame>
      <description>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 &quot;How painful do you think the person in the picture feels?&quot; 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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Empathic pain rating</measure>
      <time_frame>20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction</time_frame>
      <description>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 &quot;How pain do you think the person in the picture feels?&quot; 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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Executive function - behavior</measure>
      <time_frame>20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Executive function - EEG signal</measure>
      <time_frame>20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotional arousal</measure>
      <time_frame>20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotion regulation</measure>
      <time_frame>20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prosocial behavior level</measure>
      <time_frame>20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction</time_frame>
      <description>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 &quot;accidentally&quot; 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).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">23</enrollment>
    <condition>Sleep Restriction</condition>
    <arm_group>
      <arm_group_label>Nap rested and nap restriction</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Nap restriction</intervention_name>
      <description>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.</description>
      <arm_group_label>Nap rested and nap restriction</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. healthy, typically developing, Intelligence quotient (IQ) ≥ 85;&#xD;
  &#xD;
            2. never diagnosed with emotional-behavioral problems;&#xD;
  &#xD;
            3. sleeping on a regular daily schedule;&#xD;
  &#xD;
            4. reported napping three or more times every week, ≤ one nap in one day;&#xD;
  &#xD;
            5. able to fall asleep by themselves.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. not able to fall asleep alone;&#xD;
  &#xD;
            2. travel beyond two time zones within 3 months of the study;&#xD;
  &#xD;
            3. use of medications influencing sleep or alertness;&#xD;
  &#xD;
            4. reported or diagnosed sleep problems (such as obstructive sleep apnea (OSA),&#xD;
               narcolepsy, parasomnia, insomnia, etc.) ;&#xD;
  &#xD;
            5. history of neurodevelopmental diseases, including developmental delay, epilepsy,&#xD;
               chronic medical conditions, lead poisoning and head injuries involving loss of&#xD;
               consciousness;&#xD;
  &#xD;
            6. conceptual age &lt;35 weeks or &gt; 45 weeks;&#xD;
  &#xD;
            7. birth weight &lt; 2,500 grams;&#xD;
  &#xD;
            8. Children's Behaviors Checklist (CBCL) total score &gt; 70;&#xD;
  &#xD;
            9. a first-degree family history of diagnosed narcolepsy, psychosis or bipolar disorder.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>42 Months</minimum_age>
      <maximum_age>72 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fan Jiang, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Shanghai Children's Medical Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Guanghai Wang, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Children's Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guanghai Wang, PhD</last_name>
      <phone>021-38626161</phone>
      <email>wang-guanghai@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Guanghai Wang, PhD</last_name>
        <phone>021-58750573</phone>
        <email>wang-guanghai@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <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>
      <PMID>25394169</PMID>
    </reference>
    <reference>
      <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>
      <PMID>34904310</PMID>
    </reference>
    <reference>
      <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>
      <PMID>28523733</PMID>
    </reference>
    <reference>
      <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>
      <PMID>21600660</PMID>
    </reference>
    <reference>
      <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>
      <PMID>31894624</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>21988087</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
      <investigator_full_name>Guanghai Wang</investigator_full_name>
      <investigator_title>Developing Brain Lab</investigator_title>
    </responsible_party>
    <keyword>nap restriction</keyword>
    <keyword>preschooler</keyword>
    <keyword>socio-emotional development</keyword>
    <keyword>executive function</keyword>
    <keyword>event-related potential</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06025669
  org study id: SCMCIRB-K2022122-2
  nct id: NCT06025669
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: 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
  description: 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.
  measure: Empathic pain rating
  time frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
  description: 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.
  measure: Executive function - behavior
  time frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
  description: 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.
  measure: Executive function - EEG signal
  time frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
  description: 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.
  measure: Emotional arousal
  time frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
  description: 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.
  measure: Emotion regulation
  time frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
  description: 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.
  measure: Prosocial behavior level
  time frame: 20 minutes after waking up from scheduled nap, or 20 minutes post nap restriction
  description: 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).
  arm group label: Nap rested and nap restriction
  arm group type: Experimental
  description: 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.
  intervention type: Behavioral
  intervention name: Nap restriction
  description: 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.
  arm group label: Nap rested and nap restriction
  criteria: 
  gender: All
  minimum age: 42 Months
  maximum age: 72 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Fan Jiang, PhD
  role: Study Director
  affiliation: Shanghai Children's Medical Center
  last name: Guanghai Wang, PhD
  role: Principal Investigator
  affiliation: Shanghai Children's Medical Center
  last name: Guanghai Wang, PhD
  phone: 021-38626161
  email: wang-guanghai@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  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.
  PMID: 25394169
  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.
  PMID: 34904310
  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.
  PMID: 28523733
  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.
  PMID: 21600660
  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.
  PMID: 31894624
  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.
  PMID: 21988087
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai Jiao Tong University School of Medicine
  investigator full name: Guanghai Wang
  investigator title: Developing Brain Lab