Age-related Changes in Sleep-wake Regulation

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT03813082
• Collaborator: (none)
• Enrollment: 29
• Arms: 2
• Actual Duration (Months): 45

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Deprivation	Behavioral: Prolonged wakefulness	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 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: Mar 1, 2016
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sleep-wake induced change in cerebral availability of mGluR5 (metabotropic glutamate receptors of subtype 5) [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 [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 [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) [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) [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Zurich

Investigators

• Principal Investigator: Hanspeter Landolt, Prof, University of Zurich, Institute of Pharmacology and Toxicology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT03813082
• Other Study ID Numbers: PSS-Sleep
• First Posted: Jan 23, 2019
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Sleep Deprivation

Study Results

No Results Posted as of Jan 26, 2021