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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05319262
Other study ID # 234826201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 24, 2022
Est. completion date June 3, 2022

Study information

Verified date June 2022
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the biological mechanisms linking sleep disruption by noise and the development of disease. In a laboratory sleep study, we will play traffic sounds of different types (road, rail and air) and noise levels during the night. We will also have nights with sound from so-called "white noise machines". These generate a low-level and continuous noise that may improve sleep by "masking" the traffic noises that would otherwise disturb sleep. We 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.


Description:

The experimental sleep study has the overarching goal of deepening our understanding of experimentally-induced disruption of sleep and changes in metabolic and cognitive function, and to determine the efficacy of a potential non-pharmacological intervention to promote sleep. To this end, the study will address the following independent aims: Aim 1: Determine associations between novel physiologic markers of sleep and metabolic and cognitive function. We will measure the sleep of healthy volunteers using novel and classical indictors of sleep architecture. Each morning we will obtain blood samples for metabolomics analysis and administer a neurocognitive test battery. Aim 2: Determine the biological and neurobehavioral consequences of noise-disrupted sleep. We will compare effects on sleep, metabolomics and cognitive function between quiet nights and nights with traffic noise. Aim 3: Evaluate the effects of continuous pink noise throughout the night. Sub-aim 1: To determine if continuous noise (pink noise) per se improves or disturbs sleep, we will investigate changes in novel and classical indictors of sleep architecture and disturbance induced by pink noise relative to quiet baseline nights. Sub-aim 2: To determine if pink noise reduces sleep disturbance by traffic noise, we will investigate changes in sleep fragmentation and continuity, and cortical and autonomic arousal, from nights with both traffic noise and pink noise compared to nights with traffic noise only. The study will be conducted at in the University of Gothenburg sound environment laboratory (SEL). 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 us to create a realistic acoustic environment by transmitting sound exposures from the control room to each bedroom individually. This study has a prospective within-subjects cross-over design. Participants (N=12) 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 familiarisation with the test procedures. Study nights 2-5 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 one night of each of the following: Quiet night: No noise will be played, serving as a control night to assess individual baseline sleep, metabolic profile, and cognitive performance; Traffic noise night to determine consequences of noise-disrupted sleep; Pink noise night: To determine impact of continuous pink noise on sleep; Traffic + pink noise night: simultaneous traffic and pink noise at the same sound pressure levels as in the traffic-only and pink noise-only nights, to determine sleep-protecting effects of pink noise in the face of traffic noise. Each night we will record physiologic sleep with polysomnography (PSG) and cardiac activity with electrocardiography (ECG). Each study morning, subjects will provide a 2ml blood sample, complete cognitive testing 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 sound-induced auditory fatigue may be affected by noise exposure during participant's normal routines,60 they will wear a noise dosimeter during the week of the study to record their daytime noise exposure. Because extreme and/or variable dietary behaviour 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 performed by the research group at the University of Gothenburg, 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. Each morning, subjects will complete a computerised 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 analysed 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. Subjects will wear a noise dosimeter during the week of the study to record their daytime noise exposure (sound pressure level only, no actual sound recordings). Participants will wear a wrist actigraphy monitor continuously throughout the study period, and also for the week before the study, to confirm habitual sleep-wake times and to measure physical activity levels.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 3, 2022
Est. primary completion date June 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: 1) live in or around the city of Gothenburg area (Sweden) Exclusion Criteria: 1. aged <18 or >30 years; 2. 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); 3. BMI>25 kg/m2; 4. regular sleep medication use (prescribed or "over-the-counter"); 5. poor hearing acuity (measured during screening via pure tone audiometry); 6. diagnosed with sleep disorders; 7. indications of sleep apnea on the STOP-BANG questionnaire; 8. shift work; 9. smoking, vaping, snus, or other nicotine use; 10. pre-existing use of "white noise machines" as a sleep aid.

Study Design


Intervention

Radiation:
Pink noise exposure
Continuous pink noise sound exposure at 45 dBA, throughout the whole night
Traffic noise
120 traffic noise events (40 each of road, rail and aircraft), introduced at maximum sound pressure levels ranging between 45-65 dB LAS.max.

Locations

Country Name City State
Sweden University of Gothenburg Gothenburg Västra Götaland

Sponsors (3)

Lead Sponsor Collaborator
Göteborg University University of Manitoba, University of Pennsylvania

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Metabolomics and lipids Concentrations of 41 metabolites, including amino acids, amines, alcohols, carboxylic acids, choline, keto acids, sugars, and sulfones. Lipoprotein profile, including concentrations of triglycerides, cholesterol, phospholipids, and apolipoproteins. On each of the five study mornings
Primary Baseline total sleep time Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Control night
Primary Total sleep time during exposure to nocturnal traffic Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the traffic noise night
Primary Total sleep time during exposure to pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the pink noise night
Primary Total sleep time during exposure to traffic noise + pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Traffic noise + pink noise night
Primary Total amount of baseline N1 sleep Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Control night
Primary Total amount of baseline N2 sleep Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Control night
Primary Total amount of baseline N3 sleep Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Control night
Primary Total amount of baseline rapid eye movement (REM) sleep Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Control night
Primary Total amount of N1 sleep during exposure to nocturnal traffic Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the traffic noise night
Primary Total amount of N2 sleep during exposure to nocturnal traffic Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the traffic noise night
Primary Total amount of N3 sleep during exposure to nocturnal traffic Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the traffic noise night
Primary Total amount of rapid eye movement (REM) sleep during exposure to nocturnal traffic Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the traffic noise night
Primary Total amount of N1 sleep during exposure to pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the pink noise night
Primary Total amount of N2 sleep during exposure to pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the pink noise night
Primary Total amount of N3 sleep during exposure to pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the pink noise night
Primary Total amount of rapid eye movement (REM) sleep during exposure to pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the pink noise night
Primary Total amount of N1 sleep during exposure to traffic noise + pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Traffic noise + pink noise night
Primary Total amount of N2 sleep during exposure to traffic noise + pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Traffic noise + pink noise night
Primary Total amount of N3 sleep during exposure to traffic noise + pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Traffic noise + pink noise night
Primary Total amount of rapid eye movement (REM) sleep during exposure to traffic noise + pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Traffic noise + pink noise night
Primary Baseline wakefulness after sleep onset (WASO) 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 During the Control night
Primary Wakefulness after sleep onset (WASO) during exposure to nocturnal traffic 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 During the Traffic noise night
Primary Wakefulness after sleep onset (WASO) during exposure to pink noise 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 During the Pink noise night
Primary Wakefulness after sleep onset (WASO) during exposure to traffic noise + pink noise 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 During the Traffic noise + pink noise night
Primary Baseline number of awakenings Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Control night
Primary Number of awakenings during exposure to nocturnal traffic Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Traffic noise night
Primary Number of awakenings during exposure to pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Pink noise night
Primary Number of awakenings during exposure to traffic noise + pink noise Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines During the Traffic noise + pink noise night
Primary Baseline sleep onset latency (SOL) 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. During the Control night
Primary Sleep onset latency (SOL) during exposure to nocturnal traffic 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. During the Traffic noise night
Primary Sleep onset latency (SOL) during exposure to pink noise 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. During the Pink noise night
Primary Sleep onset latency (SOL) during exposure to nocturnal traffic and pink noise 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. During the Traffic noise + Pink noise night
Primary Baseline sleep efficiency 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. During the Control night
Primary Sleep efficiency during exposure to nocturnal traffic 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. During the Traffic noise night
Primary Sleep efficiency during exposure to pink noise 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. During the Pink noise night
Primary Sleep efficiency during exposure to nocturnal traffic and pink noise 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. During the Traffic noise + pink noise night
Primary Baseline sleep depth assessed using the odds ratio product (ORP) Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements. During the Control night
Primary Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal traffic Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements. During the Traffic noise night
Primary Sleep depth assessed using the odds ratio product (ORP) during exposure to pink noise Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements. During the Pink noise night
Primary Sleep depth assessed using the odds ratio product (ORP) during exposure to traffic noise and pink noise Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements. During the Traffic noise + pink noise night
Primary Spontaneous maximal change of odds ratio product (ORP) 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. During the Control night
Primary Maximal change of odds ratio product (ORP) during exposure to traffic noise events 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. During the Traffic noise night
Primary Maximal change of odds ratio product (ORP) during exposure to traffic noise events 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. During the Traffic noise + pink noise night
Primary Spontaneous change of odds ratio product (ORP) during exposure to pink noise 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. During the Pink noise night
Primary Baseline morning neurobehavioural speed 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) In the morning immediately after the Control night
Primary Morning neurobehavioural speed after exposure to nocturnal traffic 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) In the morning immediately after the Traffic noise night
Primary Morning neurobehavioural speed after exposure to pink noise 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) In the morning immediately after the Pink noise night
Primary Morning neurobehavioural speed after exposure to nocturnal traffic and pink noise 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) In the morning immediately after the Traffic noise + pink noise night
Primary Baseline morning neurobehavioural accuracy 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) In the morning immediately after the Control night
Primary Morning neurobehavioural accuracy after exposure to nocturnal traffic 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) In the morning immediately after the Traffic noise night
Primary Morning neurobehavioural accuracy after exposure to pink noise 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) In the morning immediately after the Pink noise night
Primary Morning neurobehavioural accuracy after exposure to nocturnal traffic and pink noise 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) In the morning immediately after the Traffic noise + pink noise night
Primary Baseline evening neurobehavioural speed 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) In the evening of the day following the Control night
Primary Evening neurobehavioural speed after exposure to nocturnal traffic 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) In the evening of the day following the Traffic noise night
Primary Evening neurobehavioural speed after exposure to pink noise 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) In the evening of the day following the Pink noise night
Primary Evening neurobehavioural speed after exposure to nocturnal traffic and pink noise 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) In the evening of the day following the Traffic noise + pink noise night
Primary Baseline evening neurobehavioural accuracy 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) In the evening of the day following the Control night
Primary Evening neurobehavioural accuracy after exposure to nocturnal traffic 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) In the evening of the day following the Traffic noise night
Primary Evening neurobehavioural accuracy after exposure to pink noise 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) In the evening of the day following the Pink noise night
Primary Evening neurobehavioural accuracy after exposure to nocturnal traffic and pink noise 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) In the evening of the day following the Traffic noise + pink noise night
Primary Baseline Ethanol concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Trimethylamine-N-oxide concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline 2-Aminobutyric acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Alanine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Asparagine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Creatine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Creatinine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Glutamic acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Glutamine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Glycine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Histidine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Isoleucine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Leucine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Lysine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Methionine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline N,N-Dimethylglycine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Ornithine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Phenylalanine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Proline concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Sarcosine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Threonine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Tyrosine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Valine concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline 2-Hydroxybutyric acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Acetic acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Citric acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Formic acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Lactic acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Succinic acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Choline concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline 2-Oxoglutaric acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline 3-Hydroxybutyric acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Acetoacetic acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Acetone concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Pyruvic acid concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline D-Galactose concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Glucose concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Glycerol concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Baseline Dimethylsulfone concentration (mmol/L) Determined from NMR analysis of blood plasma In the morning immediately after the Control night
Primary Ethanol concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Trimethylamine-N-oxide concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary 2-Aminobutyric acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Alanine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Asparagine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Creatine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Creatinine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Glutamic acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Glutamine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Glycine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Histidine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Isoleucine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Leucine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Lysine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Methionine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary N,N-Dimethylglycine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Ornithine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Phenylalanine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Proline concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Sarcosine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Threonine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Tyrosine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Valine concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary 2-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Acetic acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Citric acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Formic acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Lactic acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Succinic acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Choline concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary 2-Oxoglutaric acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary 3-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Acetoacetic acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Acetone concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Pyruvic acid concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary D-Galactose concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Glucose concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Glycerol concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Dimethylsulfone concentration (mmol/L) after exposure to nocturnal traffic Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise night
Primary Ethanol concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Trimethylamine-N-oxide concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary 2-Aminobutyric acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Alanine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Asparagine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Creatine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Creatinine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Glutamic acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Glutamine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Glycine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Histidine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Isoleucine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Leucine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Lysine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Methionine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary N,N-Dimethylglycine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Ornithine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Phenylalanine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Proline concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Sarcosine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Threonine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Tyrosine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Valine concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary 2-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Acetic acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Citric acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Formic acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Lactic acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Succinic acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Choline concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary 2-Oxoglutaric acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary 3-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Acetoacetic acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Acetone concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Pyruvic acid concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary D-Galactose concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Glucose concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Glycerol concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Dimethylsulfone concentration (mmol/L) after exposure to nocturnal pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Pink noise night
Primary Ethanol concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Trimethylamine-N-oxide concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary 2-Aminobutyric acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Alanine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Asparagine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Creatine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Creatinine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Glutamic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Glutamine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Glycine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Histidine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Isoleucine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Leucine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Lysine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Methionine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary N,N-Dimethylglycine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Ornithine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Phenylalanine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Proline concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Sarcosine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Threonine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Tyrosine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Valine concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary 2-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Acetic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Citric acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Formic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Lactic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Succinic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Choline concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary 2-Oxoglutaric acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary 3-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Acetoacetic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Acetone concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Pyruvic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary D-Galactose concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Glucose concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Glycerol concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Primary Dimethylsulfone concentration (mmol/L) after exposure to nocturnal traffic and pink noise Determined from NMR analysis of blood plasma In the morning immediately after the Traffic noise + pink noise night
Secondary Cardiovascular activation in response to noise Change in heart rate (ECG) Event-related, occurring within the time window of each discrete noise event, during each of the five study nights (23:00 to 07:00)
Secondary Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale 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) Every study evening
Secondary Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale 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) Every study morning
Secondary Evening auditory fatigue Perceived auditory fatigue, self-reported on a 5-point verbal scale, from 1 - "Not at all" (best outcome) to 5 - "Extremely" (worst outcome) Every study evening
Secondary Morning auditory fatigue Perceived auditory fatigue, self-reported on a 5-point verbal scale, from 1 - "Not at all" (best outcome) to 5 - "Extremely" (worst outcome) Every study morning
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