Metabolomics-based Sleepiness Markers

NCT05585515 | Completed

• 2 other identifiers: 2022-01273SNCTP000005089
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Keywords

metabolomics; sleep; biomarker; impairment

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  morning after experimental night (10am)

• Psychomotor Vigilance Test

  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

  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

  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

  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)

Study Arms (3)

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

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

Behavioral: Sleep deprivation

Interventions

Sleep deprivation BEHAVIORAL

Total sleep deficit of consecutive 8 hours

Sleep deprivation

Sleep restriction BEHAVIORAL

Total sleep deficit of cumulative 8 hours

Sleep restriction

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Fonds für Verkehrssicherheit FVS: collaborator

Study Sites (1)

Human Sleep Laboratory, University of Zurich

Zurich, Canton of Zurich, 8057, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36810100 DERIVED

MeSH Terms

Conditions

Sleep Deprivation; Sleepiness

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Kristina Keller, Dr

  University of Zurich, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 18, 2022
• Study Start: November 1, 2022
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: starting after publication
• Access Criteria: upon request via e-mail

Locations

CH (1)