<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/NCT03813082</url>
  </required_header>
  <id_info>
    <org_study_id>PSS-Sleep</org_study_id>
    <nct_id>NCT03813082</nct_id>
  </id_info>
  <brief_title>Age-related Changes in Sleep-wake Regulation</brief_title>
  <official_title>Age-related Changes in Sleep-wake Regulation: Effects of Sleep Loss on Possible Molecular Markers of Sleep Need</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A sleep deprivation protocol combined with state-of-the-art, simultaneous positron emission&#xD;
      tomography and magnetic resonance spectroscopy imaging will be employed to investigate the&#xD;
      effects of sleep deprivation and aging on hypothesized molecular markers of sleep need.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">September 2017</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep-wake induced change in cerebral availability of mGluR5 (metabotropic glutamate receptors of subtype 5)</measure>
    <time_frame>Change from baseline metabotropic glutamate receptors of subtype 5 availability after 33 hours of prolonged wakefulness and 8 hours of recovery sleep</time_frame>
    <description>Positron emission tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep-wake induced change in glutamate concentration in prefrontal cortex and basal ganglia</measure>
    <time_frame>Change from baseline glutamate concentration after 33 hours of prolonged wakefulness and 8 hours of recovery sleep</time_frame>
    <description>Magnetic resonance spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep-wake induced change in potential molecular markers of sleep need</measure>
    <time_frame>Change from baseline microRNA, fragile X mental retardation protein and brain-derived neurotrophic factor concentrations after 33 hours of prolonged wakefulness and 8 hours of recovery sleep</time_frame>
    <description>microRNAs, fragile X mental retardation protein, and brain-derived neurotrophic factor concentrations in peripheral blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep-wake induced change in sleep electroencephalogram (EEG)</measure>
    <time_frame>Change from all-night baseline sleep EEG in 8 hours of recovery sleep after 33 hours of prolonged wakefulness</time_frame>
    <description>Spectral composition of the EEG during sleep</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep-wake induced change in waking electroencephalogram (EEG)</measure>
    <time_frame>Change from baseline waking EEG during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep</time_frame>
    <description>Spectral composition of the EEG in wakefulness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep-wake induced change in subjective state</measure>
    <time_frame>Change from baseline sleepiness during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep</time_frame>
    <description>Subjective sleepiness as quantified with the Stanford Sleepiness Scale (range: 1 to 7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep-wake induced change in cognitive performance</measure>
    <time_frame>Change from baseline cognitive performance during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep</time_frame>
    <description>Cognitive performance battery including tasks measuring sustained attention, executive functioning and working memory</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Sleep Deprivation</condition>
  <arm_group>
    <arm_group_label>Sleep deprivation young men</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Young study participants will complete four nights in the sleep laboratory, whereas they will stay awake during one night. PET brain imaging will be conducted at the same circadian time on three consecutive afternoons (prior, during and after prolonged wakefulness). Additionally, validated tests of vigilance and cognitive performance will be administered and the brain waves will be recorded in wakefulness and sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep deprivation older men</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Older study participants will complete four nights in the sleep laboratory, whereas they will stay awake during one night. PET brain imaging will be conducted at the same circadian time on three consecutive afternoons (prior, during and after prolonged wakefulness). Additionally, validated tests of vigilance and cognitive performance will be administered and the brain waves will be recorded in wakefulness and sleep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prolonged wakefulness</intervention_name>
    <description>40 hours of prolonged wakefulness</description>
    <arm_group_label>Sleep deprivation older men</arm_group_label>
    <arm_group_label>Sleep deprivation young men</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy male individuals&#xD;
&#xD;
          -  age: 20-35 or 60-70 years&#xD;
&#xD;
          -  right-handed&#xD;
&#xD;
          -  non-smokers&#xD;
&#xD;
          -  moderate caffeine/alcohol consumption&#xD;
&#xD;
          -  normal BMI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sleep/circadian rhythms disturbances&#xD;
&#xD;
          -  former brain injuries with loss of consciousness and brain anomalies&#xD;
&#xD;
          -  drug intake/consumption&#xD;
&#xD;
          -  medication intake&#xD;
&#xD;
          -  cardiac pacemaker&#xD;
&#xD;
          -  neurological disorders&#xD;
&#xD;
          -  prior participation (during past 2 years) in radiological or nuclear experiment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hanspeter Landolt, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich, Institute of Pharmacology and Toxicology</affiliation>
  </overall_official>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Positron emission tomography</keyword>
  <keyword>Magnetic resonance spectroscopy</keyword>
  <keyword>Aging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
  </condition_browse>
  <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/NCT03813082
org study id: PSS-Sleep
nct id: NCT03813082
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A sleep deprivation protocol combined with state-of-the-art, simultaneous positron emission
      tomography and magnetic resonance spectroscopy imaging will be employed to investigate the
      effects of sleep deprivation and aging on hypothesized molecular markers of sleep need.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Sleep-wake induced change in cerebral availability of mGluR5 (metabotropic glutamate receptors of subtype 5)
time frame: Change from baseline metabotropic glutamate receptors of subtype 5 availability after 33 hours of prolonged wakefulness and 8 hours of recovery sleep
description: Positron emission tomography
measure: Sleep-wake induced change in glutamate concentration in prefrontal cortex and basal ganglia
time frame: Change from baseline glutamate concentration after 33 hours of prolonged wakefulness and 8 hours of recovery sleep
description: Magnetic resonance spectroscopy
measure: Sleep-wake induced change in potential molecular markers of sleep need
time frame: Change from baseline microRNA, fragile X mental retardation protein and brain-derived neurotrophic factor concentrations after 33 hours of prolonged wakefulness and 8 hours of recovery sleep
description: microRNAs, fragile X mental retardation protein, and brain-derived neurotrophic factor concentrations in peripheral blood
measure: Sleep-wake induced change in sleep electroencephalogram (EEG)
time frame: Change from all-night baseline sleep EEG in 8 hours of recovery sleep after 33 hours of prolonged wakefulness
description: Spectral composition of the EEG during sleep
measure: Sleep-wake induced change in waking electroencephalogram (EEG)
time frame: Change from baseline waking EEG during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep
description: Spectral composition of the EEG in wakefulness
measure: Sleep-wake induced change in subjective state
time frame: Change from baseline sleepiness during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep
description: Subjective sleepiness as quantified with the Stanford Sleepiness Scale (range: 1 to 7)
measure: Sleep-wake induced change in cognitive performance
time frame: Change from baseline cognitive performance during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep
description: Cognitive performance battery including tasks measuring sustained attention, executive functioning and working memory
arm group label: Sleep deprivation young men
arm group type: Experimental
description: Young study participants will complete four nights in the sleep laboratory, whereas they will stay awake during one night. PET brain imaging will be conducted at the same circadian time on three consecutive afternoons (prior, during and after prolonged wakefulness). Additionally, validated tests of vigilance and cognitive performance will be administered and the brain waves will be recorded in wakefulness and sleep.
arm group label: Sleep deprivation older men
arm group type: Experimental
description: Older study participants will complete four nights in the sleep laboratory, whereas they will stay awake during one night. PET brain imaging will be conducted at the same circadian time on three consecutive afternoons (prior, during and after prolonged wakefulness). Additionally, validated tests of vigilance and cognitive performance will be administered and the brain waves will be recorded in wakefulness and sleep.
intervention type: Behavioral
intervention name: Prolonged wakefulness
description: 40 hours of prolonged wakefulness
arm group label: Sleep deprivation older men
arm group label: Sleep deprivation young men
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hanspeter Landolt, Prof
role: Principal Investigator
affiliation: University of Zurich, Institute of Pharmacology and Toxicology
responsible party type: Sponsor
mesh term: Sleep Deprivation
sharing ipd: No