- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06260254
Effects of Railway Vibration on Sleep and Disease (BioVib)
Study Overview
Status
Conditions
Detailed Description
The experimental sleep study has the overarching goal of deepening understanding of sleep disruption by railway vibration and noise and changes in cardiometabolic and cognitive function. To this end, the study will address the following study aim:
Aim 1: Determine the biological and neurobehavioral consequences of sleep disruption by railway vibration. The investigators will measure the sleep of healthy volunteers, and each morning will obtain blood samples for metabolomics metabolic function analysis and administer a neurocognitive test battery. The investigators will compare effects on sleep, metabolomics, metabolic function and cognitive function between quiet nights and nights with railway traffic vibration and noise. Dose-response relationships will be determined by comparing nights with different levels of vibration.
This study will take place in the sound environment laboratory (SEL) at the University of Gothenburg Department of Occupational and Environmental Medicine. The SEL is a high fidelity research laboratory equipped to simulate a typical apartment, including three individually light-, sound- and vibration-isolated private bedrooms. Ceiling mounted speakers in each room and electrodynamic transducers mounted to the underside of each bed allow the investigators to create a realistic acoustic environment by transmitting sound and vibration exposures from the control room to each bedroom individually. The investigators have shown previously that results from this lab with high ecological validity are comparable with results from the field.
This study has a prospective within-subjects cross-over design. Participants (total N=24) will each spend five consecutive nights in the SEL, with a sleep opportunity between 23:00-07:00. Daytime sleep will be prohibited, confirmed with measures of daytime activity via wrist actigraphy monitors worn continuously throughout the study. Three subjects will take part concurrently, in separate bedrooms. The first night is a habituation period to the study protocol and for familiarization with the test procedures. The second night will be a quiet condition without noise or vibration, to determine normal baseline sleep, cardiometabolic profile, and cognitive performance. Study nights 3-5 are the vibration nights and will be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. In these vibration nights, vibration and noise from railway freight will be played into the bedrooms to determine the effects of vibration and noise on sleep, cardiometabolic function and cognitive performance. Thirty six trains will occur each night, randomly distributed across the 8-hour sleep period.
For railway vibration the investigators will use synthesized signals based on measured data, used in previous laboratory studies. It is necessary to use synthesized vibration, rather than recorded signals, so that the investigators can accurately adjust the acoustical character of the exposure as needed. Railway vibration will be accompanied by high fidelity recordings of railway freight noise. This is to maximize ecological validity of the exposures since vibration rarely occurs without noise, and to mask any mechanical sounds from the vibration transducers.
Vibration and noise exposures will reflect realistic railway freight traffic noise levels that occur in dwellings alongside railway lines in Sweden. The maximum Wm-weighted vibration amplitudes in the three vibration nights will be 0.5 mm/s, 0.7 mm/s and 0.9 mm/s respectively. Maximum sound pressure levels of individual train passages will not exceed 49.8 dB LAF,max. Trains will vary from 11.5 s to 56.9 s in duration. All vibration amplitudes will be calibrated on the mattress of the bed, under a 75 kg reference weight to simulate the bed being occupied. All sound pressure levels will be calibrated to 10 cm above the pillow in each bedroom prior to the study, so that these levels accurately reflect the noise exposure of the subjects during sleep.
Each night the investigators will record physiologic sleep with polysomnography (PSG) and cardiac activity with electrocardiography (ECG). Each study morning, subjects will provide a 2ml blood sample and answer questionnaires and will depart the SEL to follow their normal daytime routine. They will return to the SEL at 20:00 each evening to prepare for sleep measurements. Caffeine will be prohibited after 15:00 and alcohol will be prohibited at all times. Because extreme and/or variable dietary behavior can affect the metabolome/lipoprotein profile, participants will be given guidance that they should eat a similar evening meal on each day of the laboratory study, confirmed with a food diary. The actual meal itself can be different for different study participants, because the study has a within-subjects design.
Sleep will be recorded with ambulatory polysomnography (PSG) and cardiac activity with electrocardiography (ECG) and finger pulse photoplethysmogram. Data are recorded offline onto the sleep recorder, and will be downloaded and checked every study morning to ensure data quality. In addition to traditional sleep analysis, raw PSG data will be used to calculate the Odds Ratio Project, a novel metric of sleep depth and stability.
Each study morning subjects will provide a 2 ml blood sample for plasma metabolomics analysis. To ensure reliable data, blood samples will be taken at the same time every day to mitigate circadian effects, before eating or drinking anything except water, and each sample will be handled in the same way i.e. centrifuged, aliquoted and stored in -80C freezers. Subjects will eat the same food each study evening to mitigate within-subject dietary effects on the blood metabolome. Furthermore, a 2-hour oral glucose tolerance test (OGTT) will be performed in the mornings after the quiet control night (i.e. after study night 2) and after the third vibration exposure night (i.e. after study night 5). The investigators will measure response to a 75g glucose bolus at timepoints 10, 20, 30, 60, 90 and 120 minutes after the glucose administration.
Each evening, subjects will complete a computerized cognitive test battery taking approximately 20 minutes, that includes 10 tests across a range of cognitive domains (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance). Cognition data will be analyzed to determine key measures of cognitive speed and accuracy, adjusting for practice effects and the difficulty of the stimulus set.
Subjects will complete a battery of one-time validated questionnaires to measure their general health (SF-36), chronotype, noise sensitivity, habitual sleep quality, environmental sensitivity, and annoyance and sleep disturbance by noise. Subjects will also answer a questionnaire each study evening and morning, involving questions on sleepiness (Karolinska Sleepiness Scale), auditory fatigue, sleep disturbance by noise, and validated sleep and disturbance questions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Västra Götaland
-
Gothenburg, Västra Götaland, Sweden, 42650
- University of Gothenburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1) live in or around the city of Gothenburg area (Sweden)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Night
Single study night with no noise exposure, to determine normal baseline sleep.
|
|
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Experimental: Low Vibration Night
Single study night with railway vibration and noise events, to determine consequences of sleep disturbance by railway vibration at a lower level
|
Low level railway noise, not exceeding 50 dB LAF,max.
Thirty six single railway noise events.
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.
|
|
Experimental: Intermediate Vibration Night
Single study night with railway vibration and noise events, to determine consequences of sleep disturbance by railway vibration at an intermediate level
|
Low level railway noise, not exceeding 50 dB LAF,max.
Thirty six single railway noise events.
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.
|
|
Experimental: High Vibration Night
Single study night with railway vibration and noise events, to determine consequences of sleep disturbance by railway vibration at a higher level
|
Low level railway noise, not exceeding 50 dB LAF,max.
Thirty six single railway noise events.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting insulin resistance in the morning immediately after the Control night
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One night
|
Calculated using the Homeostatic model of insulin resistance (HOMA-IR)
|
One night
|
|
Total sleep time during the Control night
Time Frame: One night
|
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
|
One night
|
|
Total sleep time during the low vibration night
Time Frame: One night
|
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
|
One night
|
|
Total sleep time during the intermediate vibration night
Time Frame: One night
|
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
|
One night
|
|
Total sleep time during the high vibration night
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One night
|
Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
|
One night
|
|
Number of awakenings during exposure to low vibration
Time Frame: One night
|
Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
|
One night
|
|
Number of awakenings during exposure to intermediate vibration
Time Frame: One night
|
Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
|
One night
|
|
Number of awakenings during exposure to high vibration
Time Frame: One night
|
Measured via Polysomnography /EEG, scored according to American Academy of Sleep Medicine guidelines.
|
One night
|
|
Sleep onset latency (SOL) during the Control Night
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One night
|
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
Time Frame: One night
|
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
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to intermediate vibration
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to high vibration
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Sialic acid (GlycB) concentration after the Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Sialic acid (GlycB) concentration after exposure to low vibration
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Sialic acid (GlycB) concentration after exposure to intermediate vibration
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Sialic acid (GlycB) concentration after exposure to high vibration
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Supramolecular phospholipid composite (SPC) concentration after the Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Supramolecular phospholipid composite (SPC) concentration after exposure to low vibration
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Supramolecular phospholipid composite (SPC) concentration after exposure to intermediate vibration
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Supramolecular phospholipid composite (SPC) concentration after exposure to high vibration
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Ethanol concentration (mmol/L) after the Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Ethanol concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Ethanol concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Ethanol concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Trimethylamine-N-oxide concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Trimethylamine-N-oxide concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Trimethylamine-N-oxide concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Trimethylamine-N-oxide concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
2-Aminobutyric acid concentration (mmol/L) after exposure to Control night
Time Frame: One
|
Determined from NMR analysis of blood plasma
|
One
|
|
2-Aminobutyric acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One
|
Determined from NMR analysis of blood plasma
|
One
|
|
2-Aminobutyric acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One
|
Determined from NMR analysis of blood plasma
|
One
|
|
2-Aminobutyric acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One
|
Determined from NMR analysis of blood plasma
|
One
|
|
Alanine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Alanine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Alanine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Alanine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Asparagine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Asparagine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Asparagine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Asparagine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Creatine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Creatine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Creatine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Creatine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Creatinine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Creatinine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Creatinine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Creatinine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glutamic acid concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glutamic acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glutamic acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glutamic acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glutamine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glutamine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glutamine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glutamine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glycine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glycine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glycine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glycine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Histidine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Histidine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Histidine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Histidine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Isoleucine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Isoleucine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Isoleucine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Isoleucine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Leucine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Leucine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Leucine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Leucine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Lysine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Lysine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Lysine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Lysine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Methionine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Methionine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Methionine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Methionine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
N,N-Dimethylglycine concentration (mmol/L) after Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
N,N-Dimethylglycine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
N,N-Dimethylglycine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
N,N-Dimethylglycine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Ornithine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Ornithine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Ornithine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Ornithine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Phenylalanine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Phenylalanine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Phenylalanine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Phenylalanine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Proline concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Proline concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Proline concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Proline concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Sarcosine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Sarcosine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Sarcosine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Sarcosine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Threonine concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Threonine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Threonine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Threonine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Tyrosine concentration (mmol/L) after exposure toControl night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Tyrosine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Tyrosine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Tyrosine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Valine concentration (mmol/L) after Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Valine concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Valine concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
2-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
2-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
2-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
2-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetic acid concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetic acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetic acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetic acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Citric acid concentration (mmol/L) after Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Citric acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Citric acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Citric acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Formic acid concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Formic acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Formic acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Formic acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Lactic acid concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Lactic acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Lactic acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Lactic acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Succinic acid concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Succinic acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Succinic acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Choline concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Choline concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Choline concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Choline concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
2-Oxoglutaric acid concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
2-Oxoglutaric acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
2-Oxoglutaric acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
2-Oxoglutaric acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
3-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
3-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
3-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
3-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetoacetic acid concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetoacetic acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetoacetic acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetoacetic acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetone concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetone concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetone concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Acetone concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Pyruvic acid concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Pyruvic acid concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Pyruvic acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Pyruvic acid concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
D-Galactose concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
D-Galactose concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
D-Galactose concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
D-Galactose concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glucose concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glucose concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glucose concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glucose concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glycerol concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glycerol concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glycerol concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Glycerol concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Dimethylsulfone concentration (mmol/L) after exposure to Control night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Dimethylsulfone concentration (mmol/L) after exposure to low vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Dimethylsulfone concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Dimethylsulfone concentration (mmol/L) after exposure to high vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
|
|
Glucose tolerance in the morning after exposure to low vibration, assessed as glucose concentration 120 minutes after a glucose bolus
Time Frame: One night
|
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
Time Frame: One night
|
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
Time Frame: One night
|
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
Time Frame: One night
|
Glucose concentrations determined from plasma samples with the Hexokinase/G-6-PDH method
|
One night
|
|
Matsuda insulin sensitivity index in the morning after control exposure
Time Frame: One night
|
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
Time Frame: One night
|
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
Time Frame: One night
|
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
Time Frame: One night
|
Calculated as 10,000/square root of [fasting glucose × fasting insulin] × [mean glucose × mean insulin during oral glucose tolerance test])
|
One night
|
|
Valine concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One night
|
Determined from NMR analysis of blood plasma
|
One night
|
|
Succinic acid concentration (mmol/L) after exposure to intermediate vibration night
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
|
|
Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the control night
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
Time Frame: One 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
|
|
Stumvoll Insulin sensitivity Index in the morning after control
Time Frame: One night
|
.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
Time Frame: One night
|
.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
Time Frame: One night
|
.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
Time Frame: One night
|
.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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control
Time Frame: One night
|
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy.
great effort to keep alert, fighting sleep" (worst outcome)
|
One night
|
|
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration
Time Frame: One night
|
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy.
great effort to keep alert, fighting sleep" (worst outcome)
|
One night
|
|
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration
Time Frame: One night
|
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy.
great effort to keep alert, fighting sleep" (worst outcome)
|
One night
|
|
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration
Time Frame: One night
|
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy.
great effort to keep alert, fighting sleep" (worst outcome)
|
One night
|
|
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control
Time Frame: One night
|
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy.
great effort to keep alert, fighting sleep" (worst outcome)
|
One night
|
|
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration
Time Frame: One night
|
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy.
great effort to keep alert, fighting sleep" (worst outcome)
|
One night
|
|
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration
Time Frame: One night
|
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy.
great effort to keep alert, fighting sleep" (worst outcome)
|
One night
|
|
Self-reported sleep disturbance by vibration after control exposure
Time Frame: One night
|
Assessed on a 0-10 numerical scale, from "Not at all" to "Extremely"
|
One night
|
|
Self-reported sleep disturbance by vibration after exposure to low vibration
Time Frame: One night
|
Assessed on a 0-10 numerical scale, from "Not at all" to "Extremely"
|
One night
|
|
Self-reported sleep disturbance by vibration after exposure to intermediate vibration
Time Frame: One night
|
Assessed on a 0-10 numerical scale, from "Not at all" to "Extremely"
|
One night
|
|
Self-reported sleep disturbance by vibration after exposure to high vibration
Time Frame: One night
|
Assessed on a 0-10 numerical scale, from "Not at all" to "Extremely"
|
One night
|
|
Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after control exposure
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after control exposure
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to control
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to control
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration
Time Frame: One night.
|
PANAS is a 20-item instrument in which 20 words describing current mood and emotional state are rated on a 5-point Likert scale from "Not at all" to "Extremely".
A composite positive affect score is calculated from 10 of these.
|
One night.
|
|
Event-related cardiovascular activation in response to control
Time Frame: One night
|
Change in heart rate (ECG)
|
One night
|
|
Event-related cardiovascular activation in response to low vibration
Time Frame: One night
|
Change in heart rate (ECG)
|
One night
|
|
Event-related cardiovascular activation in response to intermediate vibration
Time Frame: One night
|
Change in heart rate (ECG)
|
One night
|
|
Event-related cardiovascular activation in response to high vibration
Time Frame: One night
|
Change in heart rate (ECG)
|
One night
|
|
Evening neurobehavioural speed
Time Frame: One night
|
Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)
|
One night
|
|
Evening neurobehavioural accuracy
Time Frame: One night
|
Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)
|
One night
|
|
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration
Time Frame: One night
|
The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy.
great effort to keep alert, fighting sleep" (worst outcome)
|
One night
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael G Smith, PhD, Göteborg University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 244826201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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