Metabolomics-based Sleepiness Markers

NCT ID: NCT05585515

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-05-18

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control

16/8 hours wake/sleep regime for 3 consecutive days at home and for consecutive 2 days in sleep laboratory

Group Type: NO_INTERVENTION

No interventions assigned to this group

Sleep restriction

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

Group Type: EXPERIMENTAL

Sleep restriction

Intervention Type: BEHAVIORAL

Total sleep deficit of cumulative 8 hours

Sleep deprivation

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

Group Type: EXPERIMENTAL

Sleep deprivation

Intervention Type: BEHAVIORAL

Total sleep deficit of consecutive 8 hours

Interventions

Sleep deprivation

Total sleep deficit of consecutive 8 hours

Intervention Type: BEHAVIORAL

Sleep restriction

Total sleep deficit of cumulative 8 hours

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• 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)

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fonds für Verkehrssicherheit FVS

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristina Keller, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, Zurich

Locations

Human Sleep Laboratory, University of Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 36810100 (View on PubMed)

Other Identifiers

SNCTP000005089

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-01273

Identifier Type: -

Identifier Source: org_study_id