Sleep DeprivationNCT03813082
Age-related Changes in Sleep-wake Regulation
A study testing Prolonged wakefulness in people with Sleep Deprivation, run by University of Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Prolonged wakefulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male individuals
- age: 20-35 or 60-70 years
- right-handed
- non-smokers
- moderate caffeine/alcohol consumption
- normal BMI
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Sleep Deprivation
- Being tested
- Prolonged wakefulness
- Keywords
- Positron emission tomography, Magnetic resonance spectroscopy, Aging
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged wakefulnessBehavioural
40 hours of prolonged wakefulness
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Prolonged wakefulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep-wake induced change in cerebral availability of mGluR5 (metabotropic glutamate receptors of subtype 5)
Positron emission tomography
Measured: 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
Magnetic resonance spectroscopy
Measured: 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
microRNAs, fragile X mental retardation protein, and brain-derived neurotrophic factor concentrations in peripheral blood
Measured: 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)
Spectral composition of the EEG during sleep
Measured: 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)
Spectral composition of the EEG in wakefulness
Measured: 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
Subjective sleepiness as quantified with the Stanford Sleepiness Scale (range: 1 to 7)
Measured: Change from baseline sleepiness during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep
Sleep-wake induced change in cognitive performance
Cognitive performance battery including tasks measuring sustained attention, executive functioning and working memory
Measured: Change from baseline cognitive performance during 33 hours of prolonged wakefulness and after 8 hours of recovery sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Mar 2016
- Primary completionSep 2017
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanspeter Landolt, Prof, Principal investigator, University of Zurich, Institute of Pharmacology and Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813082
- Sponsor's protocol ID
- PSS-Sleep
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2019
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31304973
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Changes in Sleep-wake Regulation: Effects of Sleep Loss on Possible Molecular Markers of Sleep Need
- ClinicalTrials.gov ID
- NCT03813082
- Acronym / sponsor ID
- PSS-Sleep
- Conditions
- Sleep Deprivation
- Keywords
- Positron emission tomography, Magnetic resonance spectroscopy, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation young men | Experimental | Behavioral: Prolonged wakefulnessYoung 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. |
| Sleep deprivation older men | Experimental | Behavioral: Prolonged wakefulnessOlder 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- healthy male individuals
- age: 20-35 or 60-70 years
- right-handed
- non-smokers
- moderate caffeine/alcohol consumption
Key exclusion criteria (7 listed)
- Sleep/circadian rhythms disturbances
- former brain injuries with loss of consciousness and brain anomalies
- drug intake/consumption
- medication intake
- cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged wakefulness40 hours of prolonged wakefulness | Behavioural | Sleep deprivation older men, Sleep deprivation young men |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Derived from this study: PubMed 31304973Weigend 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.
- Individual participant dataSharing planned: No
Related trials for Sleep Deprivation
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Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
Recruiting
Effect of Sleep Extension in Prevention to Sleep Deprivation
Healthy
Not yet recruiting
Evolution of Sleep in Intensive Care Unit Patients
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Active, not recruiting
The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanspeter Landolt, Prof principal investigator
University of Zurich, Institute of Pharmacology and Toxicology
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged wakefulness in people with Sleep Deprivation, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03813082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.