Brief Summary

This study will investigate the biological mechanisms linking sleep disruption by vibration and noise, and the development of cardiometabolic disease. In a laboratory sleep study, the investigators will play railway vibration of different levels during the night. The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analyzed to identify metabolic changes and indicators of diabetes risk in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which railway vibration exposure at night can lead to the development of diseases in the long term, especially metabolic disorders including diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

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

9 months study duration

Study Start

First participant enrolled

February 5, 2024

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed

8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2024

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed

Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

February 7, 2024

Last Update Submit

March 11, 2025

Conditions

Noise Exposure Sleep Disturbance Sleep Hygiene Metabolic Disturbance Cognitive Change Glucose Metabolism Disorders (Including Diabetes Mellitus)Vibration; Exposure

Keywords

neurobehavioral performanceTraffic noiseauditory fatiguepolysomnographymetabolomicsvibration

Outcome Measures

Primary Outcomes (237)

Fasting insulin resistance in the morning immediately after the Control night
Calculated using the Homeostatic model of insulin resistance (HOMA-IR)
One night
Fasting insulin resistance in the morning immediately after the low vibration night
Calculated using the Homeostatic model of insulin resistance (HOMA-IR)
One night
Fasting insulin resistance in the morning immediately after the intermediate vibration night
Calculated using the Homeostatic model of insulin resistance (HOMA-IR)
One night
Fasting insulin resistance in the morning immediately after the high vibration night
Calculated using the Homeostatic model of insulin resistance (HOMA-IR)
One night
Total sleep time during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total sleep time during the low vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total sleep time during the intermediate vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total sleep time during the high vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N1 sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N2 sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N3 sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of rapid eye movement (REM) sleep during the Control night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N1 sleep during the low vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N2 sleep during the low vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N3 sleep during the low vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of rapid eye movement (REM) sleep during the low vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N1 sleep during the intermediate vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N2 sleep during the intermediate vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N3 sleep during the intermediate vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of rapid eye movement (REM) sleep during the intermediate vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N1 sleep during the high vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N2 sleep during the high vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of N3 sleep during the high vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Total amount of rapid eye movement (REM) sleep during the high vibration night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
One night
Wakefulness after sleep onset (WASO) during the Control night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Wakefulness after sleep onset (WASO) during the low vibration night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Wakefulness after sleep onset (WASO) during the intermediate night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Wakefulness after sleep onset (WASO) during the high vibration night
Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Number of awakenings during the Control night
Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Number of awakenings during exposure to low vibration
Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Number of awakenings during exposure to intermediate vibration
Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Number of awakenings during exposure to high vibration
Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Sleep onset latency (SOL) during the Control Night
Defined as the time from lights out to the first epoch of sleep. Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Sleep onset latency (SOL) during the low vibration night
Defined as the time from lights out to the first epoch of sleep. Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Sleep onset latency (SOL) during the intermediate vibration night
Defined as the time from lights out to the first epoch of sleep. Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Sleep onset latency (SOL) during the high vibration night
Defined as the time from lights out to the first epoch of sleep. Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Sleep efficiency during the Control night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Sleep efficiency during the low vibration night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Sleep efficiency during the intermediate vibration night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
S Sleep efficiency during the high vibration night
Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.
One night
Sleep depth assessed using the odds ratio product (ORP) during the Control night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
One night
Sleep depth assessed using the odds ratio product (ORP) during the low vibration night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
One night
Sleep depth assessed using the odds ratio product (ORP) during the intermediate vibration night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
One night
Sleep depth assessed using the odds ratio product (ORP) during the high vibration night
Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.
One night
Maximal change of odds ratio product (ORP) during exposure to railway vibration events
Measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during railway vibration. Averaged over 36 vibration events during the night.
One night
Area under the curve of odds ratio product (ORP) during exposure to railway vibration events, calculated using the trapezoid rule
Measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during railway vibration. Averaged over 36 vibration events during the night.
One night
N-acetylglucosamine/galactosamine (GlycA) concentration after the Control night
Determined from NMR analysis of blood plasma
One night
N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to intermediate vibration
Determined from NMR analysis of blood plasma
One night
N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to high vibration
Determined from NMR analysis of blood plasma
One night
Sialic acid (GlycB) concentration after the Control night
Determined from NMR analysis of blood plasma
One night
Sialic acid (GlycB) concentration after exposure to low vibration
Determined from NMR analysis of blood plasma
One night
Sialic acid (GlycB) concentration after exposure to intermediate vibration
Determined from NMR analysis of blood plasma
One night
Sialic acid (GlycB) concentration after exposure to high vibration
Determined from NMR analysis of blood plasma
One night
Supramolecular phospholipid composite (SPC) concentration after the Control night
Determined from NMR analysis of blood plasma
One night
Supramolecular phospholipid composite (SPC) concentration after exposure to low vibration
Determined from NMR analysis of blood plasma
One night
Supramolecular phospholipid composite (SPC) concentration after exposure to intermediate vibration
Determined from NMR analysis of blood plasma
One night
Supramolecular phospholipid composite (SPC) concentration after exposure to high vibration
Determined from NMR analysis of blood plasma
One night
Ethanol concentration (mmol/L) after the Control night
Determined from NMR analysis of blood plasma
One night
Ethanol concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Ethanol concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Ethanol concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Trimethylamine-N-oxide concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Trimethylamine-N-oxide concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Trimethylamine-N-oxide concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Trimethylamine-N-oxide concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
2-Aminobutyric acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One
2-Aminobutyric acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One
2-Aminobutyric acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One
2-Aminobutyric acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One
Alanine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Alanine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Alanine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Alanine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Asparagine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Asparagine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Asparagine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Asparagine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Creatine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Creatine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Creatine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Creatine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Creatinine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Creatinine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Creatinine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Creatinine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Glutamic acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Glutamic acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Glutamic acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Glutamic acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Glutamine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Glutamine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Glutamine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Glutamine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Glycine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Glycine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Glycine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Glycine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Histidine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Histidine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Histidine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Histidine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Isoleucine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Isoleucine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Isoleucine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Isoleucine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Leucine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Leucine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Leucine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Leucine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Lysine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Lysine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Lysine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Lysine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Methionine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Methionine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Methionine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Methionine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
N,N-Dimethylglycine concentration (mmol/L) after Control night
Determined from NMR analysis of blood plasma
One night
N,N-Dimethylglycine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
N,N-Dimethylglycine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
N,N-Dimethylglycine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Ornithine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Ornithine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Ornithine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Ornithine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Phenylalanine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Phenylalanine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Phenylalanine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Phenylalanine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Proline concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Proline concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Proline concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Proline concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Sarcosine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Sarcosine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Sarcosine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Sarcosine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Threonine concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Threonine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Threonine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Threonine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Tyrosine concentration (mmol/L) after exposure toControl night
Determined from NMR analysis of blood plasma
One night
Tyrosine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Tyrosine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Tyrosine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Valine concentration (mmol/L) after Control night
Determined from NMR analysis of blood plasma
One night
Valine concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Valine concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Valine concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
2-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
2-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
2-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
2-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Acetic acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Acetic acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Acetic acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Acetic acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Citric acid concentration (mmol/L) after Control night
Determined from NMR analysis of blood plasma
One night
Citric acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Citric acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Citric acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Formic acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Formic acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Formic acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Formic acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Lactic acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Lactic acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Lactic acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Lactic acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Succinic acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Succinic acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Succinic acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Succinic acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Choline concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Choline concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Choline concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Choline concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
2-Oxoglutaric acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
2-Oxoglutaric acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
2-Oxoglutaric acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
2-Oxoglutaric acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
3-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
3-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
3-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
3-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Acetoacetic acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Acetoacetic acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Acetoacetic acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Acetoacetic acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Acetone concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Acetone concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Acetone concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Acetone concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Pyruvic acid concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Pyruvic acid concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Pyruvic acid concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Pyruvic acid concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
D-Galactose concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
D-Galactose concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
D-Galactose concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
D-Galactose concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Glucose concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Glucose concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Glucose concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Glucose concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Glycerol concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Glycerol concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Glycerol concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Glycerol concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Dimethylsulfone concentration (mmol/L) after exposure to Control night
Determined from NMR analysis of blood plasma
One night
Dimethylsulfone concentration (mmol/L) after exposure to low vibration night
Determined from NMR analysis of blood plasma
One night
Dimethylsulfone concentration (mmol/L) after exposure to intermediate vibration night
Determined from NMR analysis of blood plasma
One night
Dimethylsulfone concentration (mmol/L) after exposure to high vibration night
Determined from NMR analysis of blood plasma
One night
Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the control night
Area under the curve (AUC) calculated using the trapezoidal rule, from glucose samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus.
One night
Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the low vibration night
Area under the curve (AUC) calculated using the trapezoidal rule, from glucose samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus.
One night
Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the intermediate vibration night
Area under the curve (AUC) calculated using the trapezoidal rule, from glucose samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus.
One night
Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the high vibration night
Area under the curve (AUC) calculated using the trapezoidal rule, from glucose samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus.
One night
Response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night
Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus
One night
Response to an oral glucose load calculated as area under curve for insulin, in the morning after the intermediate vibration night
Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus
One night
Response to an oral glucose load calculated as area under curve for insulin, in the morning after the high vibration night
Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20, 30, 60, 90 and 120 minutes after the glucose bolus
One night
Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the control night
Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20 and 30 minutes after the glucose bolus
One night
Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night
Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20 and 30 minutes after the glucose bolus
One night
Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the intermediate vibration night
Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20 and 30 minutes after the glucose bolus
One night
Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the high vibration night
Area under the curve (AUC) calculated using the trapezoidal rule, from insulin samples collected 10, 20 and 30 minutes after the glucose bolus
One night
Glucose tolerance in the morning after exposure to low vibration, assessed as glucose concentration 120 minutes after a glucose bolus
Glucose concentrations determined from plasma samples with the Hexokinase/G-6-PDH method
One night
Glucose tolerance in the morning after exposure to intermediate vibration, assessed as glucose concentration 120 minutes after a glucose bolus
Glucose concentrations determined from plasma samples with the Hexokinase/G-6-PDH method
One night
Glucose tolerance in the morning after exposure to high vibration, assessed as glucose concentration 120 minutes after a glucose bolus
Glucose concentrations determined from plasma samples with the Hexokinase/G-6-PDH method
One night
Glucose tolerance in the morning after Control night, assessed as glucose concentration 120 minutes after a glucose bolus
Glucose concentrations determined from plasma samples with the Hexokinase/G-6-PDH method
One night
Stumvoll Insulin sensitivity Index in the morning after control
.226 - 0.0032 × BMI - 0.0000645 × I120 - 0.00375 × G90, where I120 and G90 represent insulin concentration 120 minutes after the glucose bolus, and glucose concentration 90 minutes after the glucose bolus, respectively.
One night
Stumvoll Insulin sensitivity Index in the morning after exposure to low vibration
.226 - 0.0032 × BMI - 0.0000645 × I120 - 0.00375 × G90, where I120 and G90 represent insulin concentration 120 minutes after the glucose bolus, and glucose concentration 90 minutes after the glucose bolus, respectively.
One night
Stumvoll Insulin sensitivity Index in the morning after exposure to intermediate vibration
.226 - 0.0032 × BMI - 0.0000645 × I120 - 0.00375 × G90, where I120 and G90 represent insulin concentration 120 minutes after the glucose bolus, and glucose concentration 90 minutes after the glucose bolus, respectively.
One night
Stumvoll Insulin sensitivity Index in the morning after exposure to high vibration
.226 - 0.0032 × BMI - 0.0000645 × I120 - 0.00375 × G90, where I120 and G90 represent insulin concentration 120 minutes after the glucose bolus, and glucose concentration 90 minutes after the glucose bolus, respectively.
One night
Matsuda insulin sensitivity index in the morning after control exposure
Calculated as 10,000/square root of \[fasting glucose × fasting insulin\] × \[mean glucose × mean insulin during oral glucose tolerance test\])
One night
Matsuda insulin sensitivity index in the morning after exposure to low vibration
Calculated as 10,000/square root of \[fasting glucose × fasting insulin\] × \[mean glucose × mean insulin during oral glucose tolerance test\])
One night
Matsuda insulin sensitivity index in the morning after exposure to intermediate vibration
Calculated as 10,000/square root of \[fasting glucose × fasting insulin\] × \[mean glucose × mean insulin during oral glucose tolerance test\])
One night
Matsuda insulin sensitivity index in the morning after exposure to high vibration
Calculated as 10,000/square root of \[fasting glucose × fasting insulin\] × \[mean glucose × mean insulin during oral glucose tolerance test\])
One night

Secondary Outcomes (34)

Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control
One night
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration
One night
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration
One night
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration
One night
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control
One night
+29 more secondary outcomes

Study Arms (4)

Control Night

NO INTERVENTION

Single study night with no noise exposure, to determine normal baseline sleep.

Low Vibration Night

EXPERIMENTAL

Single study night with railway vibration and noise events, to determine consequences of sleep disturbance by railway vibration at a lower level

Radiation: Railway noiseRadiation: Low level railway vibration

Intermediate Vibration Night

EXPERIMENTAL

Single study night with railway vibration and noise events, to determine consequences of sleep disturbance by railway vibration at an intermediate level

Radiation: Railway noiseRadiation: Intermediate level railway vibration

High Vibration Night

EXPERIMENTAL

Single study night with railway vibration and noise events, to determine consequences of sleep disturbance by railway vibration at a higher level

Radiation: Railway noiseRadiation: High level railway vibration

Interventions

Railway noiseRADIATION

Low level railway noise, not exceeding 50 dB LAF,max. Thirty six single railway noise events.

High Vibration NightIntermediate Vibration NightLow Vibration Night

Low level railway vibrationRADIATION

36 single railway noise events at 0.5 mm/s, varying from 11.5 s to 56.9 s in duration. Vibration always occurs concurrently with the noise exposure.

Low Vibration Night

Intermediate level railway vibrationRADIATION

36 single railway noise events at 0.7 mm/s, varying from 11.5 s to 56.9 s in duration. Vibration always occurs concurrently with the noise exposure.

Intermediate Vibration Night

High level railway vibrationRADIATION

36 single railway noise events at 0.9 mm/s, varying from 11.5 s to 56.9 s in duration. Vibration always occurs concurrently with the noise exposure.

High Vibration Night

Eligibility Criteria

Age18 Years - 30 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

\) live in or around the city of Gothenburg area (Sweden)

You may not qualify if:

aged \<18 or \>30 years;
habitual sleep and wake timings more than ±1 hour different from the study sleep times (i.e. habitual sleep time should be 22:00-00:00 and habitual wake time should be 06:00-08:00);
BMI\>25 kg/m2;
regular sleep medication use (prescribed or "over-the-counter");
poor hearing acuity (measured during screening via pure tone audiometry);
diagnosed with sleep disorders;
diagnosed with diabetes
indications of sleep apnea on the STOP-BANG questionnaire;
shift work;
smoking, vaping, snus, or other nicotine use;
pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, Västra Götaland County, 42650, Sweden

Location

MeSH Terms

Conditions

ParasomniasSleep HygieneGlucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersHealth BehaviorBehaviorMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

Michael G Smith, PhD
Göteborg University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Masking Details: Participants will be aware that in any given study night they can be exposed to railway vibration and noise. They will not be informed what exposure condition will occur in any given night, but they can become unblinded to the exposure if they are awake, as they will may hear the noise or feel the vibration. Study investigators responsible for analysing cognitive performance variables and physiological sleep data will be be blind to which vibration and noise interventions were introduced on which study nights.
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 15, 2024

Study Start

February 5, 2024

Primary Completion

June 14, 2024

Study Completion

October 31, 2024

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

SE(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (237)

Secondary Outcomes (34)

Study Arms (4)

Control Night

Low Vibration Night

Intermediate Vibration Night

High Vibration Night

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations