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Age-related Changes in Sleep-wake Regulation

Primary Purpose

Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prolonged wakefulness
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Deprivation focused on measuring Positron emission tomography, Magnetic resonance spectroscopy, Aging

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy male individuals
  • age: 20-35 or 60-70 years
  • right-handed
  • non-smokers
  • moderate caffeine/alcohol consumption
  • normal BMI

Exclusion Criteria:

  • Sleep/circadian rhythms disturbances
  • former brain injuries with loss of consciousness and brain anomalies
  • drug intake/consumption
  • medication intake
  • cardiac pacemaker
  • neurological disorders
  • prior participation (during past 2 years) in radiological or nuclear experiment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Sleep deprivation young men

    Sleep deprivation older men

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Sleep-wake induced change in cerebral availability of mGluR5 (metabotropic glutamate receptors of subtype 5)
    Positron emission tomography

    Secondary Outcome Measures

    Sleep-wake induced change in glutamate concentration in prefrontal cortex and basal ganglia
    Magnetic resonance spectroscopy
    Sleep-wake induced change in potential molecular markers of sleep need
    microRNAs, fragile X mental retardation protein, and brain-derived neurotrophic factor concentrations in peripheral blood
    Sleep-wake induced change in sleep electroencephalogram (EEG)
    Spectral composition of the EEG during sleep
    Sleep-wake induced change in waking electroencephalogram (EEG)
    Spectral composition of the EEG in wakefulness
    Sleep-wake induced change in subjective state
    Subjective sleepiness as quantified with the Stanford Sleepiness Scale (range: 1 to 7)
    Sleep-wake induced change in cognitive performance
    Cognitive performance battery including tasks measuring sustained attention, executive functioning and working memory

    Full Information

    First Posted
    January 17, 2019
    Last Updated
    January 25, 2021
    Sponsor
    University of Zurich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03813082
    Brief Title
    Age-related Changes in Sleep-wake Regulation
    Official Title
    Age-related Changes in Sleep-wake Regulation: Effects of Sleep Loss on Possible Molecular Markers of Sleep Need
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    September 2017 (Actual)
    Study Completion Date
    December 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Zurich

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Deprivation
    Keywords
    Positron emission tomography, Magnetic resonance spectroscopy, Aging

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sleep deprivation young men
    Arm Type
    Experimental
    Arm 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 Title
    Sleep deprivation older men
    Arm Type
    Experimental
    Arm 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(s)
    Prolonged wakefulness
    Intervention Description
    40 hours of prolonged wakefulness
    Primary Outcome Measure Information:
    Title
    Sleep-wake induced change in cerebral availability of mGluR5 (metabotropic glutamate receptors of subtype 5)
    Description
    Positron emission tomography
    Time Frame
    Change from baseline metabotropic glutamate receptors of subtype 5 availability after 33 hours of prolonged wakefulness and 8 hours of recovery sleep
    Secondary Outcome Measure Information:
    Title
    Sleep-wake induced change in glutamate concentration in prefrontal cortex and basal ganglia
    Description
    Magnetic resonance spectroscopy
    Time Frame
    Change from baseline glutamate concentration after 33 hours of prolonged wakefulness and 8 hours of recovery sleep
    Title
    Sleep-wake induced change in potential molecular markers of sleep need
    Description
    microRNAs, fragile X mental retardation protein, and brain-derived neurotrophic factor concentrations in peripheral blood
    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
    Title
    Sleep-wake induced change in sleep electroencephalogram (EEG)
    Description
    Spectral composition of the EEG during sleep
    Time Frame
    Change from all-night baseline sleep EEG in 8 hours of recovery sleep after 33 hours of prolonged wakefulness
    Title
    Sleep-wake induced change in waking electroencephalogram (EEG)
    Description
    Spectral composition of the EEG in wakefulness
    Time Frame
    Change from baseline waking EEG during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep
    Title
    Sleep-wake induced change in subjective state
    Description
    Subjective sleepiness as quantified with the Stanford Sleepiness Scale (range: 1 to 7)
    Time Frame
    Change from baseline sleepiness during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep
    Title
    Sleep-wake induced change in cognitive performance
    Description
    Cognitive performance battery including tasks measuring sustained attention, executive functioning and working memory
    Time Frame
    Change from baseline cognitive performance during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy male individuals age: 20-35 or 60-70 years right-handed non-smokers moderate caffeine/alcohol consumption normal BMI Exclusion Criteria: Sleep/circadian rhythms disturbances former brain injuries with loss of consciousness and brain anomalies drug intake/consumption medication intake cardiac pacemaker neurological disorders prior participation (during past 2 years) in radiological or nuclear experiment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hanspeter Landolt, Prof
    Organizational Affiliation
    University of Zurich, Institute of Pharmacology and Toxicology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31304973
    Citation
    Weigend S, Holst SC, Treyer V, O'Gorman Tuura RL, Meier J, Ametamey SM, Buck A, Landolt HP. Dynamic changes in cerebral and peripheral markers of glutamatergic signaling across the human sleep-wake cycle. Sleep. 2019 Oct 21;42(11):zsz161. doi: 10.1093/sleep/zsz161.
    Results Reference
    derived

    Learn more about this trial

    Age-related Changes in Sleep-wake Regulation

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