Low Particle Emission and Low Noise Tyres
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Baseline total sleep time during the Control night
研究概览
简要总结
This study will investigate the biological mechanisms linking sleep disruption by noise and the development of disease. In a laboratory sleep study, the investigators will play synthesised automotive tyre sounds, investigating how acoustical characteristics of tyre noise impact on sleep macrostructure, cardiometabolic profile and cognitive performance (continuous traffic flow or a few individual, but higher level, traffic pass-bys). 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 analysed to identify metabolic changes in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which chronic noise exposure at night can lead to the development of diseases in the long term, especially cardiometabolic disorders.
详细描述
The experimental sleep study has the overarching goal of deepening our understanding of sleep disruption by automotive tyre noise and changes in cardiometabolic and cognitive function. To this end, the study will address the following independent aims:
Aim 1: Determine the biological and neurobehavioural consequences of sleep disruption by tyre noise. The investigators will measure the sleep of healthy volunteers, and each morning the investigators will obtain blood samples for metabolomics analysis and administer a neurocognitive test battery. The investigators will compare effects on sleep, metabolomics and cognitive function between quiet nights and nights with road traffic noise.
Aim 2: Identify acoustical characteristics of tyre noise that are especially disturbing physiologically. The investigators will use different combinations of types of tyre noise in different noise exposure nights to determine differential effects on sleep and cardiovascular response.
This study will take place in the sound environment laboratory (SEL) at the University of Gothenburg Department of Occupational and Environmental Medicine (Arbets- och miljömedicin [AMM]). 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 allow the investigators to create a realistic acoustic environment by transmitting sound 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.
There will be two study arms, each one affording the opportunity to investigate different acoustical characteristics of tyre noise and their physiological effects. Each of these study arms has a prospective within-subjects cross-over design. Participants (study 1 N=15; study 2 N=30; total N=45 across both arms) will each spend six 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 familiarisation with the test procedures. Study nights 2-6 are the experimental nights and will be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to each of the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be aware that in any given study night they can be exposed to traffic noise. They will not be informed what noise condition will occur in any given night, but they can become unblinded to the exposure if they are awake, as they will hear the noise.
Study investigators responsible for analysing cognitive performance variables and physiological sleep data will be be blind to which noise interventions were introduced on which study nights.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. live in or around the city of Gothenburg area (Sweden)
排除标准
- •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;
- •indications of sleep apnea on the STOP-BANG questionnaire;
- •shift work;
- •smoking, vaping, snus, or other nicotine use.
结局指标
主要结局
Baseline total sleep time during the Control night
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the A1 night
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination A1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline N2 sleep during the Control night
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination A2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the B2 night
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination A1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N2 sleep during exposure to nocturnal tyre noise combination B1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination B2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline N3 sleep during the Control night
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the B1 night
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination A2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination B1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total sleep time during exposure to nocturnal tyre noise combination B2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline N1 sleep during the Control night
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of baseline rapid eye movement (REM) sleep during the Control night
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination A1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination A2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination A2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline total sleep time during the A2 night
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination A1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline number of awakenings during the Control night
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Number of awakenings during exposure to nocturnal tyre noise combination A1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Baseline sleep onset latency (SOL) during the Control night
时间窗: 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.
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A1
时间窗: 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.
Baseline sleep efficiency during the Control night
时间窗: 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.
Baseline evening neurobehavioural speed following the Control night
时间窗: 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)
Total amount of N2 sleep during exposure to nocturnal tyre noise combination B2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Number of awakenings during exposure to nocturnal tyre noise combination A2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B2
时间窗: 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.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B2
时间窗: 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.
Morning neurobehavioural speed in the morning immediately after the A2 night
时间窗: 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)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B2
时间窗: 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)
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A2
时间窗: 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)
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N3 sleep during exposure to nocturnal tyre noise combination B1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A2
时间窗: 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
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B1
时间窗: 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
Number of awakenings during exposure to nocturnal tyre noise combination B2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Sleep efficiency during exposure to nocturnal tyre noise combination A1
时间窗: 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.
Sleep efficiency during exposure to nocturnal tyre noise combination B2
时间窗: 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.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A1
时间窗: One night
Primary 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 traffic noise. Averaged over all 120 noise events during the night.
Morning neurobehavioural speed in the morning immediately after the B1 night
时间窗: 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)
Morning neurobehavioural speed in the morning immediately after the B2 night
时间窗: 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)
Morning neurobehavioural accuracy in the morning after the control night
时间窗: 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)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A2
时间窗: 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)
Total amount of N1 sleep during exposure to nocturnal tyre noise combination B1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Total amount of N1 sleep during exposure to nocturnal tyre noise combination B2
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A1
时间窗: 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
Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B2
时间窗: 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
Number of awakenings during exposure to nocturnal tyre noise combination B1
时间窗: One night
Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A2
时间窗: 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.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A1
时间窗: 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.
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A2
时间窗: 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.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A2
时间窗: One night
Primary 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 traffic noise. Averaged over all 120 noise events during the night.
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B1
时间窗: 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)
Baseline wakefulness after sleep onset (WASO) during the Control night
时间窗: 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
Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B1
时间窗: 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.
Sleep efficiency during exposure to nocturnal tyre noise combination A2
时间窗: 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.
Sleep efficiency during exposure to nocturnal tyre noise combination B1
时间窗: 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.
Baseline sleep depth assessed using the odds ratio product (ORP) during the Control night
时间窗: 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.
Spontaneous maximal change of odds ratio product (ORP) during the Control night
时间窗: One night
Primary 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 traffic noise. Averaged over 120 sham noise events during the night.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B1
时间窗: One night
Primary 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 traffic noise. Averaged over all 120 noise events during the night.
Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B2
时间窗: One night
Primary 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 traffic noise. Averaged over all 120 noise events during the night.
Morning neurobehavioural speed in the morning immediately after the Control night
时间窗: 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)
Morning neurobehavioural speed in the morning immediately after the A1 night
时间窗: 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)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A1
时间窗: 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)
Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B1
时间窗: 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)
Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B1
时间窗: 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.
Baseline evening neurobehavioural accuracy following the Control night
时间窗: One night
Average of one key speed 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
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the control night
时间窗: 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)
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A1
时间窗: 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)
Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B2
时间窗: 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)
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A2
时间窗: One night
Average of one key speed 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)
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B2
时间窗: One night
Average of one key speed 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)
Event-related Cardiovascular activation in response to noise during A2
时间窗: One night
Change in heart rate (ECG)
Event-related Cardiovascular activation in response to noise during B2
时间窗: One night
Change in heart rate (ECG)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A2 night
时间窗: 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)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the control night
时间窗: 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)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A1 night
时间窗: 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)
Serotonin concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B2 night
时间窗: 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)
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A1
时间窗: One night
Average of one key speed 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)
Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B1
时间窗: One night
Average of one key speed 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)
Event-related Cardiovascular activation in response to noise during Control night
时间窗: One night
Change in heart rate (ECG)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B2 night
时间窗: 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)
Taurine concentration (mmol/L) immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A1 night
时间窗: 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)
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Valine concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Event-related Cardiovascular activation in response to noise during A1
时间窗: One night
Change in heart rate (ECG)
Event-related Cardiovascular activation in response to noise during B1
时间窗: One night
Change in heart rate (ECG)
Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B1 night
时间窗: 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)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A2 night
时间窗: 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)
Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B1 night
时间窗: 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)
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Leucine concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Phenylalanine concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L)In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Baseline Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Basline Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Control night
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2
时间窗: One night
Determined from GC-MS analysis of blood plasma
Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1
时间窗: One night
Determined from GC-MS analysis of blood plasma
次要结局
未报告次要终点