<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/NCT03227406</url>
  </required_header>
  <id_info>
    <org_study_id>2016P000222</org_study_id>
    <secondary_id>R01MH048832</secondary_id>
    <nct_id>NCT03227406</nct_id>
  </id_info>
  <brief_title>The Evolution of Memories Across Wake and Sleep</brief_title>
  <official_title>The Evolution of Memories Across Wake and Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</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 understanding of the relationship between sleep and memory the investigators will&#xD;
      address and attempt to answer three questions, (1) how memories evolve across wake and sleep,&#xD;
      (2) how different aspects of this memory evolution are reflected both behaviorally and in the&#xD;
      EEG signal, and (3) what stages and features of sleep affect memory evolution. Together,&#xD;
      these studies will provide a greater breadth and depth of knowledge concerning sleep's role&#xD;
      in memory consolidation. Such knowledge would be of practical importance for educational&#xD;
      practices, whether in schools, on the job, or in the military, and would also provide&#xD;
      valuable information to the fields of sleep medicine and psychiatry, where interactions&#xD;
      between sleep disorders and cognitive functioning are of great importance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Goal 1: How do memories evolve across wake and sleep? The investigators are interested in how&#xD;
      specific memories are selected for change across periods of wake and sleep, and in&#xD;
      characterizing the manner in which those memories change. There has been research into broad&#xD;
      areas of memory, such as procedural and declarative memory, but other forms of memory, such&#xD;
      as semantic memory, remain unexplored, as well as different subtypes of memory within these&#xD;
      broad areas. Additionally, it is presently unknown how memories are selected for subsequent&#xD;
      processing during sleep and wake. The investigators aim to characterize which memories&#xD;
      change, how they are selected, and how they change differently over periods that include&#xD;
      sleep versus periods during which participants remain awake.&#xD;
&#xD;
      Goal 2: How are these changes reflected behaviorally and in the EEG signal? The investigators&#xD;
      will employ and develop specific behavioral and electrophysiological tasks and measures that&#xD;
      allow one to probe the state of a particular type of memory and determine how it changes over&#xD;
      periods of wake and sleep. EEG signals may be informative about the status of a memory during&#xD;
      behavioral performance as well as during both waking and sleeping offline states.&#xD;
&#xD;
      Goal 3: What stages and features of sleep affect memory evolution? In the cases in which&#xD;
      sleep in particular is found or suspected to influence memories in a unique way, the&#xD;
      investigators will assess which stages and features of sleep are involved in that evolution.&#xD;
      Generally, this will be accomplished by correlating measures such as time spent in a sleep&#xD;
      stage, prominence of particular brain oscillations, or density of spindles with changes in&#xD;
      behavior or in other EEG metrics&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">January 31, 2023</completion_date>
  <primary_completion_date type="Actual">January 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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motor sequence task improvement</measure>
    <time_frame>4-24 hrs</time_frame>
    <description>The increase in the number of correct sequences typed, from the last three training trials to the first three delayed-test trials, is calculated as a percent improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychomotor vigilance task lapse rate</measure>
    <time_frame>4-24 hrs</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>
  <primary_outcome>
    <measure>Serial reaction time test improvement</measure>
    <time_frame>4-24 hrs</time_frame>
    <description>At two time points, separated by a period of wake or sleep, the average reaction time to stimuli in repeated sequence blocks is subtracted from the average reaction time in random blocks. The percent increase in this difference, from the final blocks in the first test to the first blocks in the second test, is calculated as a percent improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual discrimination task improvement</measure>
    <time_frame>4-24 hrs</time_frame>
    <description>At two time points, separated by a period of wake or sleep, the interpolated stimulus-mask ISI corresponding to 80% accuracy on the texture discrimination task is determined, and task improvement is calculated as the difference between these thresholds, in ms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep architecture (absolute times)</measure>
    <time_frame>4-24 hrs</time_frame>
    <description>Sleep is recorded with standard polysomnography and the amount of time spent in each wake and sleep stage calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep architecture (percent times)</measure>
    <time_frame>4-24 hrs</time_frame>
    <description>The percent of total sleep time spent in each sleep stage is calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spindle</measure>
    <time_frame>4-24 hrs</time_frame>
    <description>The density of sleep spindles per minute of N2 sleep is calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep microstructure</measure>
    <time_frame>4-24 hrs</time_frame>
    <description>The EEG spectral power is calculated for N2 and N3 sleep.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">276</enrollment>
  <condition>Sleep Deprivation</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Daytime Wake</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects are trained and retested during a single period of daytime wake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Overnight sleep</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects are trained on one day and tested the next day, after a night of normal sleep</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep deprivation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are trained on one day and tested the next day, after a night of sleep deprivation</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 kept awake all night.</description>
    <arm_group_label>Sleep deprivation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nap</intervention_name>
    <description>Participants are given a 90-minute nap opportunity in the early afternoon.</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 to refrain from alcohol and recreational drugs for the duration of the&#xD;
             protocol&#xD;
&#xD;
          -  in some cases, English as a first language, normal hearing, and/or normal or corrected&#xD;
             to normal vision is required&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  self-reported sleep disturbances&#xD;
&#xD;
          -  a history of mental illness&#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>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Stickgold, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Robert Stickgold</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 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>sleep</keyword>
  <keyword>memory</keyword>
  <keyword>REM sleep</keyword>
  <keyword>slow wave sleep</keyword>
  <keyword>cognition</keyword>
  <keyword>sleep spindles</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/NCT03227406
org study id: 2016P000222
secondary id: R01MH048832
nct id: NCT03227406
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To further understanding of the relationship between sleep and memory the investigators will
      address and attempt to answer three questions, (1) how memories evolve across wake and sleep,
      (2) how different aspects of this memory evolution are reflected both behaviorally and in the
      EEG signal, and (3) what stages and features of sleep affect memory evolution. Together,
      these studies will provide a greater breadth and depth of knowledge concerning sleep's role
      in memory consolidation. Such knowledge would be of practical importance for educational
      practices, whether in schools, on the job, or in the military, and would also provide
      valuable information to the fields of sleep medicine and psychiatry, where interactions
      between sleep disorders and cognitive functioning are of great importance.
Goal 1: How do memories evolve across wake and sleep? The investigators are interested in how
      specific memories are selected for change across periods of wake and sleep, and in
      characterizing the manner in which those memories change. There has been research into broad
      areas of memory, such as procedural and declarative memory, but other forms of memory, such
      as semantic memory, remain unexplored, as well as different subtypes of memory within these
      broad areas. Additionally, it is presently unknown how memories are selected for subsequent
      processing during sleep and wake. The investigators aim to characterize which memories
      change, how they are selected, and how they change differently over periods that include
      sleep versus periods during which participants remain awake.

      Goal 2: How are these changes reflected behaviorally and in the EEG signal? The investigators
      will employ and develop specific behavioral and electrophysiological tasks and measures that
      allow one to probe the state of a particular type of memory and determine how it changes over
      periods of wake and sleep. EEG signals may be informative about the status of a memory during
      behavioral performance as well as during both waking and sleeping offline states.

      Goal 3: What stages and features of sleep affect memory evolution? In the cases in which
      sleep in particular is found or suspected to influence memories in a unique way, the
      investigators will assess which stages and features of sleep are involved in that evolution.
      Generally, this will be accomplished by correlating measures such as time spent in a sleep
      stage, prominence of particular brain oscillations, or density of spindles with changes in
      behavior or in other EEG metrics
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Motor sequence task improvement
time frame: 4-24 hrs
description: The increase in the number of correct sequences typed, from the last three training trials to the first three delayed-test trials, is calculated as a percent improvement.
measure: Psychomotor vigilance task lapse rate
time frame: 4-24 hrs
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: Serial reaction time test improvement
time frame: 4-24 hrs
description: At two time points, separated by a period of wake or sleep, the average reaction time to stimuli in repeated sequence blocks is subtracted from the average reaction time in random blocks. The percent increase in this difference, from the final blocks in the first test to the first blocks in the second test, is calculated as a percent improvement.
measure: Visual discrimination task improvement
time frame: 4-24 hrs
description: At two time points, separated by a period of wake or sleep, the interpolated stimulus-mask ISI corresponding to 80% accuracy on the texture discrimination task is determined, and task improvement is calculated as the difference between these thresholds, in ms.
measure: Sleep architecture (absolute times)
time frame: 4-24 hrs
description: Sleep is recorded with standard polysomnography and the amount of time spent in each wake and sleep stage calculated.
measure: Sleep architecture (percent times)
time frame: 4-24 hrs
description: The percent of total sleep time spent in each sleep stage is calculated.
measure: Spindle
time frame: 4-24 hrs
description: The density of sleep spindles per minute of N2 sleep is calculated.
measure: Sleep microstructure
time frame: 4-24 hrs
description: The EEG spectral power is calculated for N2 and N3 sleep.
arm group label: Daytime Wake
arm group type: No Intervention
description: Subjects are trained and retested during a single period of daytime wake
arm group label: Overnight sleep
arm group type: No Intervention
description: Subjects are trained on one day and tested the next day, after a night of normal sleep
arm group label: Sleep deprivation
arm group type: Experimental
description: Subjects are trained on one day and tested the next day, after a night of sleep deprivation
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 kept awake all night.
arm group label: Sleep deprivation
intervention type: Behavioral
intervention name: Nap
description: Participants are given a 90-minute nap opportunity in the early afternoon.
arm group label: Daytime Nap
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Stickgold, PhD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
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