Age-related Changes in Sleep-wake Regulation

January 25, 2021 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline metabotropic glutamate receptors of subtype 5 availability after 33 hours of prolonged wakefulness and 8 hours of recovery sleep

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline glutamate concentration after 33 hours of prolonged wakefulness and 8 hours of recovery sleep
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
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
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
Change from all-night baseline sleep EEG in 8 hours of recovery sleep after 33 hours of prolonged wakefulness
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
Change from baseline waking EEG during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep
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)
Change from baseline sleepiness during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep
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
Change from baseline cognitive performance during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSS-Sleep

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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