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Age-related Changes in Sleep-wake Regulation

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ClinicalTrials.gov Identifier: NCT03813082
Recruitment Status : Active, not recruiting
First Posted : January 23, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Sleep Deprivation Behavioral: Prolonged wakefulness Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Age-related Changes in Sleep-wake Regulation: Effects of Sleep Loss on Possible Molecular Markers of Sleep Need
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Sleep deprivation young men
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.
Behavioral: Prolonged wakefulness
40 hours of prolonged wakefulness

Experimental: Sleep deprivation older men
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.
Behavioral: Prolonged wakefulness
40 hours of prolonged wakefulness




Primary Outcome Measures :
  1. 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 ]
    Positron emission tomography


Secondary Outcome Measures :
  1. 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 ]
    Magnetic resonance spectroscopy

  2. 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 ]
    microRNAs, fragile X mental retardation protein, and brain-derived neurotrophic factor concentrations in peripheral blood

  3. 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 ]
    Spectral composition of the EEG during sleep

  4. 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 ]
    Spectral composition of the EEG in wakefulness

  5. 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 ]
    Subjective sleepiness as quantified with the Stanford Sleepiness Scale (range: 1 to 7)

  6. 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 ]
    Cognitive performance battery including tasks measuring sustained attention, executive functioning and working memory



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813082


Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Hanspeter Landolt, Prof University of Zurich, Institute of Pharmacology and Toxicology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03813082     History of Changes
Other Study ID Numbers: PSS-Sleep
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Positron emission tomography
Magnetic resonance spectroscopy
Aging
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders