<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/NCT03285880</url>
  </required_header>
  <id_info>
    <org_study_id>R01HL111695</org_study_id>
    <nct_id>NCT03285880</nct_id>
  </id_info>
  <brief_title>The Benefits of Naps on Cognitive, Emotional, and Motor Learning in Preschoolers</brief_title>
  <official_title>The Benefits of Naps on Cognitive, Emotional, and Motor Learning in Preschoolers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Amherst</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Massachusetts, Amherst</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific objective of the proposed research is to examine whether naps contribute to&#xD;
      immediate and delayed benefits on multiple forms of learning in young children (3-5 yrs). By&#xD;
      probing recall prior to and following mid-day nap or wake intervals, the overarching&#xD;
      hypothesis is that recent memories are actively processed (as opposed to passively protected)&#xD;
      by a nap, conferring immediate or delayed (24-hrs) benefits on declarative (Aim 1),&#xD;
      procedural (Aim 2), and emotional (Aim 3) memories. In two conditions, children will either&#xD;
      be nap-promoted or wake-promoted midday. Subsequently, performance will be reassessed that&#xD;
      day as well as the following day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed research examines whether naps contribute to immediate and delayed benefits on&#xD;
      multiple forms of learning in preschool-aged children (3-5 yrs). By probing recall prior to&#xD;
      and following mid-day nap or wake intervals, we will examine immediate memory performance and&#xD;
      how it is changed by an interval with a nap compared to if that interval was spent awake.&#xD;
      There are three arm, separately assessing declarative (using a storybook learning task),&#xD;
      procedural (using a mirror tracing task), and emotional (using an emotional storybook task).&#xD;
      All children will participate in a nap and wake condition. On the experimental day, children&#xD;
      will learn the task, then be nap or wake promoted (within subject, conditions counterbalanced&#xD;
      and separated by 1 week). Subsequently, performance will be reassessed that day as well as&#xD;
      the following day. Children will wear an actigraph watch for a 16-day interval surrounding&#xD;
      the experimental days in order to access habitual sleep patterns (e.g., nap frequency). A&#xD;
      subset of children will complete the experimental days in the sleep laboratory. For these&#xD;
      children, sleep will be measured using polysomnography, a montage of electroencepholography,&#xD;
      electromyography, and electrooculography electrodes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The pandemic halted the study protocol temporarily. We continued to collect what we could but&#xD;
    the study ran out of time/funds.&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Within subject comparison of nap and wake conditions</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Within-subject; participants/experimenters are aware of conditions</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in memory accuracy</measure>
    <time_frame>4-5 hours</time_frame>
    <description>Accuracy on the memory task following the nap compared to before the nap relative to the same memory change measured over an interval spent awake</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">361</enrollment>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Declarative memory</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Napping v. wake effect on a declarative memory task (storybook)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Procedural memory</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Napping v. wake effect on a procedural memory task (motor sequence learning or mirror tracing)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Emotional memory</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Napping v. wake effect on an emotional memory task (emotional faces or storybook)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Napping</intervention_name>
    <description>Children nap during the nap opportunity</description>
    <arm_group_label>Declarative memory</arm_group_label>
    <arm_group_label>Emotional memory</arm_group_label>
    <arm_group_label>Procedural memory</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be enrolled in a preschool testing site or available to come into the lab&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of any sleep disorder(other than mild parasomnia) past or present&#xD;
&#xD;
          -  Current use of psychotropic or sleep-altering medications&#xD;
&#xD;
          -  traveling beyond 1 time zone within 1 month of testing&#xD;
&#xD;
          -  fever or symptoms of respiratory illness at the time of testing&#xD;
&#xD;
          -  physical handicap which interferes with assessments (vision, hearing impairment)&#xD;
&#xD;
          -  diagnosed developmental disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>33 Months</minimum_age>
    <maximum_age>60 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca M Spencer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Massachusetts, Amherst</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Massachusetts</name>
      <address>
        <city>Amherst</city>
        <state>Massachusetts</state>
        <zip>01003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cognaclab.com</url>
    <description>Lab website</description>
  </link>
  <reference>
    <citation>Kurdziel L, Duclos K, Spencer RM. Sleep spindles in midday naps enhance learning in preschool children. Proc Natl Acad Sci U S A. 2013 Oct 22;110(43):17267-72. doi: 10.1073/pnas.1306418110. Epub 2013 Sep 23.</citation>
    <PMID>24062429</PMID>
  </reference>
  <reference>
    <citation>Desrochers PC, Kurdziel LB, Spencer RM. Delayed benefit of naps on motor learning in preschool children. Exp Brain Res. 2016 Mar;234(3):763-72. doi: 10.1007/s00221-015-4506-3. Epub 2015 Dec 8.</citation>
    <PMID>26645305</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Amherst</investigator_affiliation>
    <investigator_full_name>Rebecca Spencer</investigator_full_name>
    <investigator_title>Associate Professor of Psychological and Brain Sciences</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03285880
org study id: R01HL111695
nct id: NCT03285880
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The specific objective of the proposed research is to examine whether naps contribute to
      immediate and delayed benefits on multiple forms of learning in young children (3-5 yrs). By
      probing recall prior to and following mid-day nap or wake intervals, the overarching
      hypothesis is that recent memories are actively processed (as opposed to passively protected)
      by a nap, conferring immediate or delayed (24-hrs) benefits on declarative (Aim 1),
      procedural (Aim 2), and emotional (Aim 3) memories. In two conditions, children will either
      be nap-promoted or wake-promoted midday. Subsequently, performance will be reassessed that
      day as well as the following day.
The proposed research examines whether naps contribute to immediate and delayed benefits on
      multiple forms of learning in preschool-aged children (3-5 yrs). By probing recall prior to
      and following mid-day nap or wake intervals, we will examine immediate memory performance and
      how it is changed by an interval with a nap compared to if that interval was spent awake.
      There are three arm, separately assessing declarative (using a storybook learning task),
      procedural (using a mirror tracing task), and emotional (using an emotional storybook task).
      All children will participate in a nap and wake condition. On the experimental day, children
      will learn the task, then be nap or wake promoted (within subject, conditions counterbalanced
      and separated by 1 week). Subsequently, performance will be reassessed that day as well as
      the following day. Children will wear an actigraph watch for a 16-day interval surrounding
      the experimental days in order to access habitual sleep patterns (e.g., nap frequency). A
      subset of children will complete the experimental days in the sleep laboratory. For these
      children, sleep will be measured using polysomnography, a montage of electroencepholography,
      electromyography, and electrooculography electrodes.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Within subject comparison of nap and wake conditions
primary purpose: Basic Science
masking: None (Open Label)
masking description: Within-subject; participants/experimenters are aware of conditions
measure: Change in memory accuracy
time frame: 4-5 hours
description: Accuracy on the memory task following the nap compared to before the nap relative to the same memory change measured over an interval spent awake
arm group label: Declarative memory
arm group type: Experimental
description: Napping v. wake effect on a declarative memory task (storybook)
arm group label: Procedural memory
arm group type: Experimental
description: Napping v. wake effect on a procedural memory task (motor sequence learning or mirror tracing)
arm group label: Emotional memory
arm group type: Experimental
description: Napping v. wake effect on an emotional memory task (emotional faces or storybook)
intervention type: Behavioral
intervention name: Napping
description: Children nap during the nap opportunity
arm group label: Declarative memory
arm group label: Emotional memory
arm group label: Procedural memory
criteria: 
gender: All
minimum age: 33 Months
maximum age: 60 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Rebecca M Spencer, PhD
role: Principal Investigator
affiliation: University of Massachusetts, Amherst
facility: 
country: United States
url: http://www.cognaclab.com
description: Lab website
citation: Kurdziel L, Duclos K, Spencer RM. Sleep spindles in midday naps enhance learning in preschool children. Proc Natl Acad Sci U S A. 2013 Oct 22;110(43):17267-72. doi: 10.1073/pnas.1306418110. Epub 2013 Sep 23.
PMID: 24062429
citation: Desrochers PC, Kurdziel LB, Spencer RM. Delayed benefit of naps on motor learning in preschool children. Exp Brain Res. 2016 Mar;234(3):763-72. doi: 10.1007/s00221-015-4506-3. Epub 2015 Dec 8.
PMID: 26645305
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Amherst
investigator full name: Rebecca Spencer
investigator title: Associate Professor of Psychological and Brain Sciences
sharing ipd: No