NCT05611619

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

September 23, 2022

Last Update Submit

January 3, 2024

Conditions

Noise ExposureSleep DisturbanceSleep HygieneMetabolic DisturbanceCognitive Change

Keywords

Neurobehavioural PerformancePolysomnographyMetabolomics

Outcome Measures

Primary Outcomes (179)

  • Baseline total sleep time during the Control night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Baseline total sleep time during the A1 night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Baseline total sleep time during the A2 night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Baseline total sleep time during the B1 night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Baseline total sleep time during the B2 night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total sleep time during exposure to nocturnal tyre noise combination A1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total sleep time during exposure to nocturnal tyre noise combination A2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total sleep time during exposure to nocturnal tyre noise combination B1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total sleep time during exposure to nocturnal tyre noise combination B2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of baseline N1 sleep during the Control night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of baseline N2 sleep during the Control night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of baseline N3 sleep during the Control night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of baseline rapid eye movement (REM) sleep during the Control night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N1 sleep during exposure to nocturnal tyre noise combination A1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N2 sleep during exposure to nocturnal tyre noise combination A1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N3 sleep during exposure to nocturnal tyre noise combination A1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N1 sleep during exposure to nocturnal tyre noise combination A2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N2 sleep during exposure to nocturnal tyre noise combination A2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N3 sleep during exposure to nocturnal tyre noise combination A2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N1 sleep during exposure to nocturnal tyre noise combination B1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N2 sleep during exposure to nocturnal tyre noise combination B1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N3 sleep during exposure to nocturnal tyre noise combination B1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N1 sleep during exposure to nocturnal tyre noise combination B2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N2 sleep during exposure to nocturnal tyre noise combination B2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of N3 sleep during exposure to nocturnal tyre noise combination B2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Baseline wakefulness after sleep onset (WASO) during the Control night

    Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A1

    Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A2

    Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B1

    Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B2

    Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Baseline number of awakenings during the Control night

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Number of awakenings during exposure to nocturnal tyre noise combination A1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Number of awakenings during exposure to nocturnal tyre noise combination A2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Number of awakenings during exposure to nocturnal tyre noise combination B1

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Number of awakenings during exposure to nocturnal tyre noise combination B2

    Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines

    One night

  • Baseline sleep onset latency (SOL) during the Control night

    Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.

    One night

  • Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A1

    Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.

    One night

  • Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A2

    Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.

    One night

  • Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B1

    Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.

    One night

  • Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B2

    Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.

    One night

  • Baseline sleep efficiency during the Control night

    Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.

    One night

  • Sleep efficiency during exposure to nocturnal tyre noise combination A1

    Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.

    One night

  • Sleep efficiency during exposure to nocturnal tyre noise combination A2

    Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.

    One night

  • Sleep efficiency during exposure to nocturnal tyre noise combination B1

    Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.

    One night

  • Sleep efficiency during exposure to nocturnal tyre noise combination B2

    Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.

    One night

  • Baseline sleep depth assessed using the odds ratio product (ORP) during the Control night

    Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.

    One night

  • Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A1

    Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.

    One night

  • Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A2

    Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.

    One night

  • Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B1

    Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.

    One night

  • Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B2

    Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.

    One night

  • Spontaneous maximal change of odds ratio product (ORP) during the Control 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.

    One night

  • Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A1

    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.

    One night

  • Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A2

    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.

    One night

  • Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B1

    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.

    One night

  • Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B2

    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.

    One night

  • Morning neurobehavioural speed in the morning immediately after the Control night

    Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)

    One night

  • Morning neurobehavioural speed in the morning immediately after the A1 night

    Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)

    One night

  • Morning neurobehavioural speed in the morning immediately after the A2 night

    Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)

    One night

  • Morning neurobehavioural speed in the morning immediately after the B1 night

    Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)

    One night

  • Morning neurobehavioural speed in the morning immediately after the B2 night

    Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)

    One night

  • Morning neurobehavioural accuracy in the morning after the control night

    Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)

    One night

  • Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A1

    Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)

    One night

  • Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A2

    Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)

    One night

  • Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B1

    Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)

    One night

  • Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B2

    Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)

    One night

  • Baseline evening neurobehavioural speed following the Control night

    Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)

    One night

  • Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A1

    Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)

    One night

  • Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A2

    Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)

    One night

  • Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B1

    Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)

    One night

  • Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B2

    Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)

    One night

  • Baseline evening neurobehavioural accuracy following the Control 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

    One night

  • Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A1

    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)

    One night

  • Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A2

    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)

    One night

  • Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B1

    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)

    One night

  • Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B2

    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)

    One night

  • Event-related Cardiovascular activation in response to noise during Control night

    Change in heart rate (ECG)

    One night

  • Event-related Cardiovascular activation in response to noise during A1

    Change in heart rate (ECG)

    One night

  • Event-related Cardiovascular activation in response to noise during A2

    Change in heart rate (ECG)

    One night

  • Event-related Cardiovascular activation in response to noise during B1

    Change in heart rate (ECG)

    One night

  • Event-related Cardiovascular activation in response to noise during B2

    Change in heart rate (ECG)

    One night

  • Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the control night

    The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)

    One night

  • Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A1 night

    The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)

    One night

  • Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A2 night

    The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)

    One night

  • Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B1 night

    The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)

    One night

  • Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B2 night

    The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)

    One night

  • Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the control night

    The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)

    One night

  • Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A1 night

    The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)

    One night

  • Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A2 night

    The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)

    One night

  • Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B1 night

    The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)

    One night

  • Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B2 night

    The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)

    One night

  • Taurine concentration (mmol/L) immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Serotonin concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Tryptophan concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Isoleucine concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Leucine concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Valine concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Lauroylcarnitine (C12:0) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Phenylalanine concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 32:1 concentration (mmol/L)In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Basline Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

  • Baseline Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Control night

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1

    Determined from GC-MS analysis of blood plasma

    One night

  • Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2

    Determined from GC-MS analysis of blood plasma

    One night

Study Arms (9)

Control

NO INTERVENTION

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

Study 1: High level continuous flow tyre noise (A1)

EXPERIMENTAL

Single study night in first experimental study arm, with traffic noise to determine consequences of sleep disturbance by high level, continuous flow traffic noise. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.

Radiation: Tyre noise - continuous flowRadiation: High noise level

Study 1: Medium level continuous flow tyre noise (B1)

EXPERIMENTAL

Single study night in first experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level, continuous flow traffic noise. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.

Radiation: Tyre noise - continuous flowRadiation: Moderate noise level

Study 1: High level, discrete traffic tyre noise (A2)

EXPERIMENTAL

Single study night in first experimental study arm, with traffic noise events to determine consequences of sleep disturbance by high level traffic noise comprised of single, discrete traffic events. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.

Radiation: Tyre noise - discrete eventsRadiation: High noise level

Study 1: Medium level, discrete traffic tyre noise (B2)

EXPERIMENTAL

Single study night in first experimental study arm, with traffic noise events to determine consequences of sleep disturbance by moderate level traffic noise comprised of single, discrete traffic events. Noise will include mix of different acoustical characteristics of tyre noise throughout the night.

Radiation: Tyre noise - discrete eventsRadiation: Moderate noise level

Study 2: Medium level composite wheel tyre noise (A1)

EXPERIMENTAL

Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level traffic noise comprised of composite wheel types.

Radiation: Moderate noise levelRadiation: Composite tyres

Study 2: Low level composite wheel tyre noise (B1)

EXPERIMENTAL

Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by low level traffic noise comprised of composite wheel types.

Radiation: Low noise levelRadiation: Composite tyres

Study 2: Medium level air-filled tyre noise (A2)

EXPERIMENTAL

Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by medium level traffic noise comprised of traditional air-filled wheel types.

Radiation: Moderate noise levelRadiation: Air-filled tyres

Study 2: Low level air-filled tyre noise (B2)

EXPERIMENTAL

Single study night in second experimental study arm, with traffic noise to determine consequences of sleep disturbance by low level traffic noise comprised of traditional air-filled wheel types.

Radiation: Low noise levelRadiation: Air-filled tyres

Interventions

Tyre noise - continuous flowRADIATION

Tyre noise from continuous traffic, throughout the night

Study 1: High level continuous flow tyre noise (A1)Study 1: Medium level continuous flow tyre noise (B1)
Tyre noise - discrete eventsRADIATION

Tyre noise from few, discrete traffic events, occurring throughout the night

Study 1: High level, discrete traffic tyre noise (A2)Study 1: Medium level, discrete traffic tyre noise (B2)
High noise levelRADIATION

Tyre noise corresponding up to 65 dB LAEq,24h

Study 1: High level continuous flow tyre noise (A1)Study 1: High level, discrete traffic tyre noise (A2)
Moderate noise levelRADIATION

Tyre noise corresponding up to 60 dB LAEq,24h

Study 1: Medium level continuous flow tyre noise (B1)Study 1: Medium level, discrete traffic tyre noise (B2)Study 2: Medium level air-filled tyre noise (A2)Study 2: Medium level composite wheel tyre noise (A1)
Low noise levelRADIATION

Tyre noise corresponding up to 55 dB LAEq,24h

Study 2: Low level air-filled tyre noise (B2)Study 2: Low level composite wheel tyre noise (B1)
Air-filled tyresRADIATION

Tyre noise from traditional, air-filled tyres

Study 2: Low level air-filled tyre noise (B2)Study 2: Medium level air-filled tyre noise (A2)
Composite tyresRADIATION

Tyre noise from newly designed, airless composite tyres

Study 2: Low level composite wheel tyre noise (B1)Study 2: Medium level composite wheel tyre noise (A1)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, Västra Götaland County, 42650, Sweden

Location

MeSH Terms

Conditions

ParasomniasSleep Hygiene

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersHealth BehaviorBehavior

Study Officials

  • Michael G Smith, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be aware that in any given study night they can be exposed to 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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: There will be two separate study periods, 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. The order of the noise exposure conditions will be 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: One quiet night: No noise will be played, serving as a control night to assess individual baseline sleep, cardiometabolic profile, and cognitive performance; Four traffic noise nights: Tyre noise from road traffic noise be played into the rooms to determine the effects of noise on sleep, cardiometabolic function and cognitive performance. These noise nights will be in a 2×2 factorial design so that we can examine each combination of two specific noise characteristics.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

November 10, 2022

Study Start

January 30, 2023

Primary Completion

June 16, 2023

Study Completion

December 15, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)