<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/NCT01730742</url>
  </required_header>
  <id_info>
    <org_study_id>192837465</org_study_id>
    <nct_id>NCT01730742</nct_id>
  </id_info>
  <brief_title>Sleep Deprivation's Regulation of Immune System Function and Behavior</brief_title>
  <acronym>SS</acronym>
  <official_title>The Role of Sleep Deprivation in the Regulation of Immune System, Neuroendocrine Responses, and Behavioral Measures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uppsala University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study proposes to investigate whether sleep deprivation will affect a variety of&#xD;
      measures, including hormones, immune system functioning, and behaviors related to food intake&#xD;
      and hunger. It is predicted that sleep deprivation will affect circulating neutrophil&#xD;
      activity, and do so via affects on DNA methylation. It is also predicted that sleep&#xD;
      deprivation will up-regulate ghrelin, and down-regulate circulating oxytocin. Finally, it is&#xD;
      predicted that sleep deprivation will increase participants' tendencies to pick larger&#xD;
      portions of food, and also increase their tendency to purchase foods that are more caloric in&#xD;
      a mock supermarket scenario.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">March 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neutrophil phagocytotic function production</measure>
    <time_frame>Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention)</time_frame>
    <description>This project is designed to test the inflammatory capacity of circulating neutrophils. It also aims to investigate if any changes in neutrophil efficacy are governed by alterations in DNA methylation.&#xD;
Measured during 36 hours (at 1930 day 1, 0730 and 1930 day 2, 0730 day 3)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Portion Size Task</measure>
    <time_frame>Change in selected portion size from baseline to 1 hr after consuming a caloric preload</time_frame>
    <description>Participants will be evaluated on their tendency to choose larger or smaller portions of a variety of meal items on a computer screen. This will be conducted both following sleep deprivation and sleep, and changes over the hour will be compared between these conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuro-economics task</measure>
    <time_frame>Change in purchasing behaviour 1 hr after consuming a caloric preload</time_frame>
    <description>Participants will be evaluated on their purchasing behavior with regards to high-calorie and low-calorie food items in a mock supermarket scenario following sleep and sleep deprivation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating hormone levels</measure>
    <time_frame>Change in circulating hormone levels from baseline (ie. 1930 - before sleep intervention) to 12hr later (0730 after the nighttime intervention)</time_frame>
    <description>Participants will have their circulating hormone levels taken and analyzed, including ghrelin and oxytocin, to determine if sleep deprivation alters hormone levels related primarily to obesity or weight gain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Sleep Deprivation</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Sleep deprivation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total sleep deprivation: participants were required to stay up for the entire night before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sleep: participants had an 8-h sleep opportunity before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neuroeconomics task</intervention_name>
    <description>After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).</description>
    <arm_group_label>Sleep</arm_group_label>
    <arm_group_label>Sleep deprivation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Portion Size Task</intervention_name>
    <description>Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume</description>
    <arm_group_label>Sleep</arm_group_label>
    <arm_group_label>Sleep deprivation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>After a night of wakefulness, a blood sample was taken to assess the level and efficacy of circulating neutrophils, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as oxytocin and ghrelin</description>
    <arm_group_label>Sleep</arm_group_label>
    <arm_group_label>Sleep deprivation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Age 18-35y&#xD;
&#xD;
          -  Healthy (self-reported) and not on medication&#xD;
&#xD;
          -  Non-smoking&#xD;
&#xD;
          -  Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major illness&#xD;
&#xD;
          -  Taking any serious medications&#xD;
&#xD;
          -  Any sleep conditions (e.g. irregular bedtimes, sleep complaints)&#xD;
&#xD;
          -  Any dietary issues with the food items provided&#xD;
&#xD;
          -  A history of endocrine or psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Benedict, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>dept. of Neuroscience, Uppsala University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uppsala University</name>
      <address>
        <city>Uppsala</city>
        <zip>75105</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 15, 2012</last_update_submitted>
  <last_update_submitted_qc>November 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
  </condition_browse>
  <!-- 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/NCT01730742
org study id: 192837465
nct id: NCT01730742
lead sponsor: 
has dmc: No
The study proposes to investigate whether sleep deprivation will affect a variety of
      measures, including hormones, immune system functioning, and behaviors related to food intake
      and hunger. It is predicted that sleep deprivation will affect circulating neutrophil
      activity, and do so via affects on DNA methylation. It is also predicted that sleep
      deprivation will up-regulate ghrelin, and down-regulate circulating oxytocin. Finally, it is
      predicted that sleep deprivation will increase participants' tendencies to pick larger
      portions of food, and also increase their tendency to purchase foods that are more caloric in
      a mock supermarket scenario.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Neutrophil phagocytotic function production
time frame: Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention)
description: This project is designed to test the inflammatory capacity of circulating neutrophils. It also aims to investigate if any changes in neutrophil efficacy are governed by alterations in DNA methylation.
Measured during 36 hours (at 1930 day 1, 0730 and 1930 day 2, 0730 day 3)
measure: Portion Size Task
time frame: Change in selected portion size from baseline to 1 hr after consuming a caloric preload
description: Participants will be evaluated on their tendency to choose larger or smaller portions of a variety of meal items on a computer screen. This will be conducted both following sleep deprivation and sleep, and changes over the hour will be compared between these conditions.
measure: Neuro-economics task
time frame: Change in purchasing behaviour 1 hr after consuming a caloric preload
description: Participants will be evaluated on their purchasing behavior with regards to high-calorie and low-calorie food items in a mock supermarket scenario following sleep and sleep deprivation.
measure: Circulating hormone levels
time frame: Change in circulating hormone levels from baseline (ie. 1930 - before sleep intervention) to 12hr later (0730 after the nighttime intervention)
description: Participants will have their circulating hormone levels taken and analyzed, including ghrelin and oxytocin, to determine if sleep deprivation alters hormone levels related primarily to obesity or weight gain
arm group label: Sleep deprivation
arm group type: Experimental
description: Total sleep deprivation: participants were required to stay up for the entire night before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed
arm group label: Sleep
arm group type: Experimental
description: Sleep: participants had an 8-h sleep opportunity before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed
intervention type: Behavioral
intervention name: Neuroeconomics task
description: After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).
arm group label: Sleep
arm group label: Sleep deprivation
intervention type: Behavioral
intervention name: Portion Size Task
description: Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume
arm group label: Sleep
arm group label: Sleep deprivation
intervention type: Procedure
intervention name: Blood sample
description: After a night of wakefulness, a blood sample was taken to assess the level and efficacy of circulating neutrophils, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as oxytocin and ghrelin
arm group label: Sleep
arm group label: Sleep deprivation
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christian Benedict, PhD
role: Principal Investigator
affiliation: dept. of Neuroscience, Uppsala University
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Sleep Deprivation