Sleep DeprivationME-SMARTNCT05585515
Metabolomics-based Sleepiness Markers
A study testing Sleep deprivation and Sleep restriction in people with Sleep Deprivation and Sleepiness, run by University of Zurich at 1 site in Switzerland.
Trial summary
Estimating that people sleep on average up to two hours less over the last decades, sleepiness and fatigue need to be considered as significant societal problems of the modern world. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleepiness, Insufficient Sleep Syndrome
- What is being tested?
- Sleep deprivation and Sleep restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2022to 18 May 2023
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- understanding and spoken command of German language
- good health condition
- Body Mass Index between 18.5-24.9 kg/m2
- habitual average sleep duration between 7-9 hours / night
- habitual consumption of 3 or fewer caffeinated beverages / day
- habitual consumption of 5 or fewer alcoholic beverages / week
Show all 10Show fewer
- good sleep quality: Pittsburgh Sleep Quality Index score ≤ 5
- reasonable oral hygiene (≥1 tooth brushing / day)
- normal or corrected-to-normal vision
- car driving license holder since at least 2 years (obtained in a country with right hand traffic) and regular driver (≥ 1 per week)
Who cannot join
- two or more time zone crossings in the last 3 months
- habitual napper
- history or presence of neurological disorder, psychiatric disorder, cardiovascular disorder, dental disorder or any disorder that could pose a risk in participating or that could possibly influence study measurements
- history or presence of a sleep disorder (screening night)
- use of illicit drugs (urinary drug screening)
- use of current medication (urinary drug screening) known to influence study measurements
Show all 18Show fewer
- extreme chronotype (reduced Morningness-Eveningness-Questionnaire score ≤7 or ≥22)
- current smoker
- habitual use of energy drinks (>1 / week)
- severe skin allergies or hypersensitivities
- food allergies
- hospital stay in past 6 months
- shift worker, night worker
- recent past (last 3 months) or present Covid-19 infection
- fainting at the sight of blood or needles
- participation in a clinical study less than 30 days ago or is currently participating in other clinical studies
- simulator sickness syndrome
- refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Human Sleep Laboratory, University of Zurich
Zurich, Canton of Zurich, 8057
About this study
Official title: Study of Identification of Metabolomics-based Sleepiness Markers for Risk Prevention and Traffic Safety
Estimating that people sleep on average up to two hours less over the last decades, sleepiness and fatigue need to be considered as significant societal problems of the modern world. Jurisdiction is precise on how to deal with overtired offenders since they were not allowed to use machines or vehicles in the first place, similar to drunk individuals or consumers of illicit drugs. In contrast to alcohol or illicit drug use, however, there are no quick roadside or workplace tests as objective (analytical) biomarkers for sleepiness.
Investigators hypothesize that increasing sleep drive or impaired wakefulness can be assessed by qualitative or quantitative fluctuations of certain metabolites in biological specimens, e.g., accumulation or decrease of endogenous substances related to sleep debt. Thus, this sleep study provides the necessary biological samples of either sleep-deprived, sleep-restricted, or control subjects, which are then analysed for appropriate metabolite biomarkers utilizing an untargeted metabolomics approach. In addition to established impairment tests, a state of the art driving simulator will be employed to objectively measure driving performance under all study conditions. Participants will also rate their subjective sleepiness using validated questionnaires.
- Conditions
- Sleep Deprivation, Sleepiness, Insufficient Sleep Syndrome
- Being tested
- Sleep deprivation, Sleep restriction
- Keywords
- metabolomics, sleep, biomarker, impairment
- Medical subject headings
- Sleep Deprivation, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationBehavioural
Total sleep deficit of consecutive 8 hours
Sleep restrictionBehavioural
Total sleep deficit of cumulative 8 hours
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 16/8 hours wake/sleep regime for 3 consecutive days at home and for consecutive 2 days in sleep laboratory |
| Sleep restriction | Experimental | 18/6 hours wake/sleep regime for 3 consecutive days at home and one day in sleep laboratory, followed by recovery night of 8 hours sleep Receives: Behavioral: Sleep restriction |
| Sleep deprivation | Experimental | 16/8 hours wake/sleep regime for 3 consecutive days at home, one night of sleep deprivation (24/0 hours) in sleep laboratory, followed by recovery night of 8 hours sleep Receives: Behavioral: Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in metabolite concentrations in oral fluid quantified by liquid chromatography with mass spectrometry
Investigators will collect oral fluid samples from participants for quantification of all detectable metabolites. Investigators will analyze which metabolite concentration values undergo significant changes during sleep deficit conditions in comparison to control condition and also show effects of recovery sleep. These will serve as candidate biomarkers.
Measured: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Secondary outcomes (11)
Driving performance
Investigators will gather driving simulation results via Standardized Application for Fitness to Drive Evaluations (S.A.F.E. scale), and analyze their changes after sleep deficit in comparison to control condition. This scale has a range from 0 (best) to 10 (worst) in full steps.
Measured: morning after experimental night (10am)
Psychomotor Vigilance Test
The Psychomotor Vigilance Test is a gold standard reaction time test to assess vigilance and sustained attention.
Measured: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
d2 Test of Attention
The d2 Test of Attention is a paper and pencil test to assess selective and sustained attention and visual scanning speed.
Measured: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Visual attention test
The visual attention test is a virtual reality glasses test to assess visual skills in a complex visual environment.
Measured: After arrival at study site (8pm, baseline), repeatedly during scheduled wakefulness (10am, 2pm, 6pm, 8pm), and morning after recovery night of 8 hours of sleep (8am)
Subjective situational sleepiness
Participants will complete the Karolinska Sleepiness Scale questionnaire.
Measured: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Subjective sleepiness
Participants will complete the Stanford Sleepiness Scale questionnaire.
Measured: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Electroencephalographic changes
Investigators will analyze changes in sleep and wake electroencephalographic patterns of participants by calculating sleep scores according to American Academy of Sleep Medicine (AASM) scoring manual.
Measured: During scheduled sleep, driving simulation test (10am), and at two time points during scheduled wakefulness (12pm, 7pm)
Behavioral markers of drowsy driving
Investigators will examine participants after driving simulation test for behavioral abnormalities concerning orientation, coordination, speech, mood, appearance, reaction, and pupillary light reflex.
Measured: Once per study arm after driving simulation test (11am)
Changes in metabolite concentrations in exhaled breath quantified by liquid chromatography with mass spectrometry
Investigators will collect exhaled breath samples from participants for quantification of all detectable metabolites. Investigators will analyze which metabolite concentration values undergo significant changes during sleep deficit conditions in comparison to control condition and also show effects of recovery sleep. These will serve as secondary candidate biomarkers.
Measured: After arrival at study site (8pm, baseline), repeatedly during scheduled wakefulness (10am, 2pm, 6pm, 8pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Changes in metabolite concentrations in finger sweat quantified by liquid chromatography with mass spectrometry
Investigators will collect finger sweat samples from participants for quantification of all detectable metabolites. Investigators will analyze which metabolite concentration values undergo significant changes during sleep deficit conditions in comparison to control condition and also show effects of recovery sleep. These will serve as secondary candidate biomarkers.
Measured: After arrival at study site (8pm, baseline), repeatedly during scheduled wakefulness (10am, 2pm, 6pm, 8pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Correlation of metabolic changes between blood and non-invasive specimens
Investigators will compare metabolite concentrations in non-invasive matrices (oral fluid, finger sweat, exhaled breath, and dried blood spots) and compare those with blood sample.
Measured: immediately after driving simulation test (11am)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Nov 2022
- Primary completion18 May 2023
- Study completion18 May 2023
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds für Verkehrssicherheit FVS
- Responsible party
- Sponsor
- Investigators
- Kristina Keller, Dr, Principal investigator, University of Zurich, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585515
- Sponsor's protocol ID
- 2022-01273
- Other IDs
- SNCTP000005089
- Acronym
- ME-SMART
- Status last verified
- May 2023
- First submitted
- 5 Oct 2022
- Last updated
- 2 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be published in peer-reviewed journals. Anonymized raw data will be made available upon request.
Publications
Scholz M, Lakaemper S, Keller K, Dobay A, Steuer AE, Landolt HP, Kraemer T. Metabolomics-based Sleepiness Markers for Risk Prevention and Traffic Safety (ME-SMART): a monocentric, controlled, randomized, crossover trial. Trials. 2023 Feb 21;24(1):131. doi: 10.1186/s13063-023-07154-x.
PubMed 36810100
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Identification of Metabolomics-based Sleepiness Markers for Risk Prevention and Traffic Safety
- ClinicalTrials.gov ID
- NCT05585515
- Acronym / sponsor ID
- ME-SMART / 2022-01273
- Conditions
- Sleep Deprivation, Sleepiness, Insufficient Sleep Syndrome
- Keywords
- metabolomics, sleep, biomarker, impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Fonds für Verkehrssicherheit FVS
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 18 Oct 2022 (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.
Estimating that people sleep on average up to two hours less over the last decades, sleepiness and fatigue need to be considered as significant societal problems of the modern world. Jurisdiction is precise on how to deal with overtired offenders since they were not allowed to use machines or vehicles in the first place, similar to drunk individuals or consumers of illicit drugs. In contrast to alcohol or illicit drug use, however, there are no quick roadside or workplace tests as objective (analytical) biomarkers for sleepiness.
Investigators hypothesize that increasing sleep drive or impaired wakefulness can be assessed by qualitative or quantitative fluctuations of certain metabolites in biological specimens, e.g., accumulation or decrease of endogenous substances related to sleep debt. Thus, this sleep study provides the necessary biological samples of either sleep-deprived, sleep-restricted, or control subjects, which are then analysed for appropriate metabolite biomarkers utilizing an untargeted metabolomics approach. In addition to established impairment tests, a state of the art driving simulator will be employed to objectively measure driving performance under all study conditions. Participants will also rate their subjective sleepiness using validated questionnaires.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –16/8 hours wake/sleep regime for 3 consecutive days at home and for consecutive 2 days in sleep laboratory |
| Sleep restriction | Experimental | Behavioral: Sleep restriction18/6 hours wake/sleep regime for 3 consecutive days at home and one day in sleep laboratory, followed by recovery night of 8 hours sleep |
| Sleep deprivation | Experimental | Behavioral: Sleep deprivation16/8 hours wake/sleep regime for 3 consecutive days at home, one night of sleep deprivation (24/0 hours) in sleep laboratory, followed by recovery night of 8 hours sleep |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- understanding and spoken command of German language
- good health condition
- Body Mass Index between 18.5-24.9 kg/m2
- habitual average sleep duration between 7-9 hours / night
- habitual consumption of 3 or fewer caffeinated beverages / day
Key exclusion criteria (18 listed)
- two or more time zone crossings in the last 3 months
- habitual napper
- history or presence of neurological disorder, psychiatric disorder, cardiovascular disorder, dental disorder or any disorder that could pose a risk in participating or that could possibly influence study measurements
- history or presence of a sleep disorder (screening night)
- use of illicit drugs (urinary drug screening)
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 |
|---|---|---|
| Sleep deprivationTotal sleep deficit of consecutive 8 hours | Behavioural | Sleep deprivation |
| Sleep restrictionTotal sleep deficit of cumulative 8 hours | Behavioural | Sleep restriction |
Primary outcome
Changes in metabolite concentrations in oral fluid quantified by liquid chromatography with mass spectrometry
Time frame: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Investigators will collect oral fluid samples from participants for quantification of all detectable metabolites. Investigators will analyze which metabolite concentration values undergo significant changes during sleep deficit conditions in comparison to control condition and also show effects of recovery sleep. These will serve as candidate biomarkers.
11 secondary outcomes
Driving performance
Time frame: morning after experimental night (10am)
Psychomotor Vigilance Test
Time frame: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
d2 Test of Attention
Time frame: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Visual attention test
Time frame: After arrival at study site (8pm, baseline), repeatedly during scheduled wakefulness (10am, 2pm, 6pm, 8pm), and morning after recovery night of 8 hours of sleep (8am)
Subjective situational sleepiness
Time frame: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Subjective sleepiness
Time frame: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Electroencephalographic changes
Time frame: During scheduled sleep, driving simulation test (10am), and at two time points during scheduled wakefulness (12pm, 7pm)
Behavioral markers of drowsy driving
Time frame: Once per study arm after driving simulation test (11am)
Changes in metabolite concentrations in exhaled breath quantified by liquid chromatography with mass spectrometry
Time frame: After arrival at study site (8pm, baseline), repeatedly during scheduled wakefulness (10am, 2pm, 6pm, 8pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Changes in metabolite concentrations in finger sweat quantified by liquid chromatography with mass spectrometry
Time frame: After arrival at study site (8pm, baseline), repeatedly during scheduled wakefulness (10am, 2pm, 6pm, 8pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)
Correlation of metabolic changes between blood and non-invasive specimens
Time frame: immediately after driving simulation test (11am)
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 2 Jun 2023.
- Derived from this study: PubMed 36810100Scholz M, Lakaemper S, Keller K, Dobay A, Steuer AE, Landolt HP, Kraemer T. Metabolomics-based Sleepiness Markers for Risk Prevention and Traffic Safety (ME-SMART): a monocentric, controlled, randomized, crossover trial. Trials. 2023 Feb 21;24(1):131. doi: 10.1186/s13063-023-07154-x.
- Individual participant dataSharing planned: Yes. Results will be published in peer-reviewed journals. Anonymized raw data will be made available upon request.
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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.
Kristina Keller, Dr principal investigator
University of Zurich, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation and Sleep restriction in people with Sleep Deprivation and Sleepiness, run by University of Zurich at 1 site in Switzerland.
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 10 inclusion and 18 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 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes in metabolite concentrations in oral fluid quantified by liquid chromatography with mass spectrometry (time frame: After arrival at study site (6pm, baseline), repeatedly during scheduled wakefulness (8am, 12pm, 4pm, 7pm, 11pm), and morning after recovery night of 8 hours of sleep (8am)). 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 NCT05585515, 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 2 Jun 2023.