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Completed

NCT Number: NCT03813082

Age-related Changes in Sleep-wake Regulation

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.

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Key information

Conditions

Sleep Deprivation Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

20 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged wakefulness

Behavioral

40 hours of prolonged wakefulness

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Age-related Changes in Sleep-wake Regulation: Effects of Sleep Loss on Possible Molecular Markers of Sleep Need

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jan 23, 2019
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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