<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/NCT03767426</url>
  </required_header>
  <id_info>
    <org_study_id>TC-1</org_study_id>
    <nct_id>NCT03767426</nct_id>
  </id_info>
  <brief_title>The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity</brief_title>
  <official_title>The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</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>
      To further understand the impact of acute sleep deprivation and recovery sleep on the&#xD;
      processing of emotional information the investigators will address and attempt to answer&#xD;
      three questions, (i) how both undisturbed sleep and sleep deprivation affect the processing&#xD;
      and retrieval of emotional information, (ii) what neural and psychophysiological mechanisms&#xD;
      are associated with these behavioral effects, and (iii) to explore the ability of recovery&#xD;
      sleep to reverse the effects of sleep deprivation. Together, these studies will provide a&#xD;
      greater breadth and depth of knowledge concerning sleep's role in emotion processing and&#xD;
      regulation. Given the growing societal tendency to view sleep as unproductive-foregoing it to&#xD;
      lengthen work days and increase social opportunities- such knowledge would be of practical&#xD;
      importance for understanding the role of sleep in healthy emotional functioning, particular&#xD;
      for individuals experiencing periods of increased stress and emotional distress (e.g., new&#xD;
      parents, hospital staff, or combat troops).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Goal 1: How does sleep deprivation impact emotion perception and memory processing? The&#xD;
      investigators are interested in how an acute loss of sleep impairs our ability to properly&#xD;
      perceive, consolidate, and retrieve emotional information. There has been research on the&#xD;
      effect of sleep deprivation on broad areas of cognition, such as attention, working memory,&#xD;
      and reasoning ability, but the impact of sleep loss on emotional processing and regulation&#xD;
      remains largely unexplored. The investigators aim to characterize how sleep deprivation&#xD;
      compared to undisturbed sleep affects the ability to accurately perceive emotion, how it&#xD;
      alters the intensity with which emotions are perceived, and the effect that these changes&#xD;
      have on the subsequent consolidation and memory retrieval for emotional compared to neutral&#xD;
      information.&#xD;
&#xD;
      Goal 2: How are these changes reflected in the neural signal and with psychophysiological&#xD;
      measures? The investigators will utilize functional magnetic resonance imaging (fMRI) and&#xD;
      measures of autonomic reactivity (heart rate and skin conductance) to characterize the neural&#xD;
      and psychophysiological mechanisms underlying these behavioral changes following sleep&#xD;
      deprivation compared to a normal night of sleep. This will allow us to pinpoint the brain&#xD;
      regions involved in changes following sleep deprivation, and associate these changes with&#xD;
      effects on downstream physiological responses.&#xD;
&#xD;
      Goal 3: Can a nap after sleep deprivation restore normal processing of emotional memory and&#xD;
      rescue the neural and autonomic markers of sleep deprivation? The investigators are&#xD;
      interested in determining if a brief period of recovery sleep is enough to combat the&#xD;
      behavioral, neural, and autonomic effects of acute sleep loss, thus a portion of the&#xD;
      sleep-deprived participants will be given a 2-hour nap opportunity to quantify its&#xD;
      restorative effects. Such information would form the foundation for future research extending&#xD;
      and translating these findings into effective sleep-based interventions for healthy and&#xD;
      clinical populations alike.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Independent group comparison</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphed Face Accuracy and Intensity</measure>
    <time_frame>1-24 hours</time_frame>
    <description>Participants are asked to identify and rate emotional intensity of ambiguous emotional faces (happy, sad, angry) that have been morphed with neutral faces. Scores for each emotional domain will be calculated as (i) accuracy score (number of faces correctly identified over total faces seen), and (ii) average emotional intensity rating. Task will be completed at baseline, post-sleep/sleep deprivation, and post-nap/no nap, and within-subject comparisons will determine how interventions impact emotional perception.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Memory Tradeoff Memory Score</measure>
    <time_frame>12-24 hours</time_frame>
    <description>Following sleep or sleep deprivation, participants will complete emotional memory tradeoff recognition task at two time points, separated by a nap or wakefulness. Corrected hit rate will be calculated for negative and neutral scene components as the percentage of correctly identified &quot;old&quot; objects/backgrounds minus percentage of false alarms (&quot;new&quot; pictures marked as &quot;old&quot;)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychomotor vigilance task lapse rate</measure>
    <time_frame>1-24 hours</time_frame>
    <description>The absolute number of trials in a 5-min test period on which the participant fails to responds with 500ms is calculated as the lapse rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fMRI measured neural reactivity (blood oxygen-level dependent signal)</measure>
    <time_frame>12-24 hours</time_frame>
    <description>Following sleep or sleep deprivation, regions of interest include amygdala reactivity and connectivity between the amygdala and the ventromedial prefrontal cortex (vmPFC) in response to negative and neutral stimuli.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Reactivity (Beats per minute)</measure>
    <time_frame>12-24 hours</time_frame>
    <description>The change in heart rate beats per minute in response to negative and neutral stimuli after sleep or sleep deprivation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Conductance Reactivity (micro Siemens)</measure>
    <time_frame>12-24 hours</time_frame>
    <description>The change in electrodermal activity in response to negative and neutral stimuli after sleep or sleep deprivation.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Sleep Deprivation</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Overnight sleep</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects are permitted a night of polysomnograph-recorded sleep before participating in training and testing sessions the next day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep deprivation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects sleep deprived before participating in training and testing sessions the next day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Daytime Nap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are trained and then retested after a daytime nap</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Deprivation</intervention_name>
    <description>Subjects are sleep deprived for an entire night</description>
    <arm_group_label>Daytime Nap</arm_group_label>
    <arm_group_label>Sleep deprivation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Daytime nap</intervention_name>
    <description>After a night of sleep deprivation, participants will be given a 2 hour nap opportunity</description>
    <arm_group_label>Daytime Nap</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willing and able to follow the protocol&#xD;
&#xD;
          -  willing and able to meet inclusion criteria for fMRI scanning&#xD;
&#xD;
          -  willing to refrain from alcohol and recreational drugs for the duration of the&#xD;
             protocol&#xD;
&#xD;
          -  normal or corrected to normal vision is required&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  self-reported sleep disturbances&#xD;
&#xD;
          -  left-handedness or ambidexterity&#xD;
&#xD;
          -  a history of mental illness or neurological disorder&#xD;
&#xD;
          -  the use of any drugs that could affect either sleep or cognitive functioning (e.g.,&#xD;
             sleeping pills or antidepressants)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tony Cunningham, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tony J Cunningham, PhD</last_name>
    <phone>617-632-7927</phone>
    <email>acunnin4@bidmc.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert Stickgold, PhD</last_name>
    <phone>617-233-3768</phone>
    <email>rstickgold@hms.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tony Cunningham</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tony Cunningham, PhD</last_name>
      <phone>617-632-7927</phone>
      <email>acunnin4@bidmc.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Robert Stickgold, PhD</last_name>
      <phone>617-233-3768</phone>
      <email>rstickgold@hms.harvard.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Robert Stickgold, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>February 4, 2023</last_update_submitted>
  <last_update_submitted_qc>February 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Robert Stickgold</investigator_full_name>
    <investigator_title>Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Emotion</keyword>
  <keyword>Memory</keyword>
  <keyword>Sleep</keyword>
  <keyword>Sleep Deprivation</keyword>
  <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/NCT03767426
org study id: TC-1
nct id: NCT03767426
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To further understand the impact of acute sleep deprivation and recovery sleep on the
      processing of emotional information the investigators will address and attempt to answer
      three questions, (i) how both undisturbed sleep and sleep deprivation affect the processing
      and retrieval of emotional information, (ii) what neural and psychophysiological mechanisms
      are associated with these behavioral effects, and (iii) to explore the ability of recovery
      sleep to reverse the effects of sleep deprivation. Together, these studies will provide a
      greater breadth and depth of knowledge concerning sleep's role in emotion processing and
      regulation. Given the growing societal tendency to view sleep as unproductive-foregoing it to
      lengthen work days and increase social opportunities- such knowledge would be of practical
      importance for understanding the role of sleep in healthy emotional functioning, particular
      for individuals experiencing periods of increased stress and emotional distress (e.g., new
      parents, hospital staff, or combat troops).
Goal 1: How does sleep deprivation impact emotion perception and memory processing? The
      investigators are interested in how an acute loss of sleep impairs our ability to properly
      perceive, consolidate, and retrieve emotional information. There has been research on the
      effect of sleep deprivation on broad areas of cognition, such as attention, working memory,
      and reasoning ability, but the impact of sleep loss on emotional processing and regulation
      remains largely unexplored. The investigators aim to characterize how sleep deprivation
      compared to undisturbed sleep affects the ability to accurately perceive emotion, how it
      alters the intensity with which emotions are perceived, and the effect that these changes
      have on the subsequent consolidation and memory retrieval for emotional compared to neutral
      information.

      Goal 2: How are these changes reflected in the neural signal and with psychophysiological
      measures? The investigators will utilize functional magnetic resonance imaging (fMRI) and
      measures of autonomic reactivity (heart rate and skin conductance) to characterize the neural
      and psychophysiological mechanisms underlying these behavioral changes following sleep
      deprivation compared to a normal night of sleep. This will allow us to pinpoint the brain
      regions involved in changes following sleep deprivation, and associate these changes with
      effects on downstream physiological responses.

      Goal 3: Can a nap after sleep deprivation restore normal processing of emotional memory and
      rescue the neural and autonomic markers of sleep deprivation? The investigators are
      interested in determining if a brief period of recovery sleep is enough to combat the
      behavioral, neural, and autonomic effects of acute sleep loss, thus a portion of the
      sleep-deprived participants will be given a 2-hour nap opportunity to quantify its
      restorative effects. Such information would form the foundation for future research extending
      and translating these findings into effective sleep-based interventions for healthy and
      clinical populations alike.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Independent group comparison
primary purpose: Basic Science
masking: None (Open Label)
measure: Morphed Face Accuracy and Intensity
time frame: 1-24 hours
description: Participants are asked to identify and rate emotional intensity of ambiguous emotional faces (happy, sad, angry) that have been morphed with neutral faces. Scores for each emotional domain will be calculated as (i) accuracy score (number of faces correctly identified over total faces seen), and (ii) average emotional intensity rating. Task will be completed at baseline, post-sleep/sleep deprivation, and post-nap/no nap, and within-subject comparisons will determine how interventions impact emotional perception.
measure: Emotional Memory Tradeoff Memory Score
time frame: 12-24 hours
description: Following sleep or sleep deprivation, participants will complete emotional memory tradeoff recognition task at two time points, separated by a nap or wakefulness. Corrected hit rate will be calculated for negative and neutral scene components as the percentage of correctly identified "old" objects/backgrounds minus percentage of false alarms ("new" pictures marked as "old")
measure: Psychomotor vigilance task lapse rate
time frame: 1-24 hours
description: The absolute number of trials in a 5-min test period on which the participant fails to responds with 500ms is calculated as the lapse rate.
measure: fMRI measured neural reactivity (blood oxygen-level dependent signal)
time frame: 12-24 hours
description: Following sleep or sleep deprivation, regions of interest include amygdala reactivity and connectivity between the amygdala and the ventromedial prefrontal cortex (vmPFC) in response to negative and neutral stimuli.
measure: Heart Rate Reactivity (Beats per minute)
time frame: 12-24 hours
description: The change in heart rate beats per minute in response to negative and neutral stimuli after sleep or sleep deprivation.
measure: Skin Conductance Reactivity (micro Siemens)
time frame: 12-24 hours
description: The change in electrodermal activity in response to negative and neutral stimuli after sleep or sleep deprivation.
arm group label: Overnight sleep
arm group type: No Intervention
description: Subjects are permitted a night of polysomnograph-recorded sleep before participating in training and testing sessions the next day
arm group label: Sleep deprivation
arm group type: Active Comparator
description: Subjects sleep deprived before participating in training and testing sessions the next day
arm group label: Daytime Nap
arm group type: Experimental
description: Subjects are trained and then retested after a daytime nap
intervention type: Behavioral
intervention name: Sleep Deprivation
description: Subjects are sleep deprived for an entire night
arm group label: Daytime Nap
arm group label: Sleep deprivation
intervention type: Behavioral
intervention name: Daytime nap
description: After a night of sleep deprivation, participants will be given a 2 hour nap opportunity
arm group label: Daytime Nap
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tony Cunningham, PhD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
last name: Tony J Cunningham, PhD
phone: 617-632-7927
email: acunnin4@bidmc.harvard.edu
last name: Robert Stickgold, PhD
phone: 617-233-3768
email: rstickgold@hms.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Robert Stickgold
investigator title: Professor of Psychiatry
mesh term: Sleep Deprivation