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Sleep RestrictionNCT06025669

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

A study testing Nap restriction in people with Sleep Restriction, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 42 to 72 monthsHealthy volunteers can take part
Conditions the study is for
Sleep Restriction
What is being tested?
Nap restriction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
6 Sep 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 42 to 72 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality

Other trials in China

About this study

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.

Read the 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.

Being tested
Nap restriction
Keywords
nap restriction, preschooler, socio-emotional development, executive function, event-related potential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nap restrictionBehavioural

    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.

Study groups in NCT06025669
Study groupRoleWhat they receive
Nap rested and nap restrictionExperimentalThere 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.
Receives: Behavioral: Nap restriction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (5)

  1. Executive function - behavior

    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.

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

  2. Executive function - EEG signal

    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.

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

  3. Emotional arousal

    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.

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

  4. Emotion regulation

    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.

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

  5. Prosocial behavior level

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2023
  2. Study start6 Sep 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06025669
Sponsor's protocol ID
SCMCIRB-K2022122-2
Status last verified
Jan 2024
First submitted
7 Aug 2023
Last updated
5 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25394169

  • 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.

    PubMed 34904310

  • 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.

    PubMed 28523733

  • 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.

    PubMed 21600660

  • 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.

    PubMed 31894624

  • 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.

    PubMed 21988087

Questions about this trial

What is this clinical trial studying?

A study testing Nap restriction in people with Sleep Restriction, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06025669, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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