NCT03813082

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

January 17, 2019

Last Update Submit

January 25, 2021

Conditions

Sleep Deprivation

Keywords

Positron emission tomographyMagnetic resonance spectroscopyAging

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • Sleep-wake induced change in subjective state

    Change from baseline sleepiness during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep

  • +1 more secondary outcomes

Study Arms (2)

Sleep deprivation young men

EXPERIMENTAL

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

Sleep deprivation older men

EXPERIMENTAL

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

Interventions

Prolonged wakefulnessBEHAVIORAL

40 hours of prolonged wakefulness

Sleep deprivation older menSleep deprivation young men

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31304973DERIVED

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Hanspeter Landolt, Prof

    University of Zurich, Institute of Pharmacology and Toxicology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 23, 2019

Study Start

March 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 1, 2019

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share