NCT05319262

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

April 24, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

March 9, 2022

Last Update Submit

June 16, 2022

Conditions

Noise ExposureSleep DisturbanceSleep HygieneMetabolic DisturbanceCognitive Change

Keywords

neurobehavioral performancewhite noiseauditory fatiguepolysomnographymetabolomics

Outcome Measures

Primary Outcomes (217)

  • 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

  • Baseline total sleep time

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

    During the Control night

  • 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

  • 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

  • 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

  • Total amount of baseline N1 sleep

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

    During the Control night

  • Total amount of baseline N2 sleep

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

    During the Control night

  • Total amount of baseline N3 sleep

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

    During the Control night

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Baseline number of awakenings

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

    During the Control night

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Baseline Ethanol concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Trimethylamine-N-oxide concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline 2-Aminobutyric acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Alanine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Asparagine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Creatine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Creatinine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Glutamic acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Glutamine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Glycine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Histidine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Isoleucine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Leucine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Lysine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Methionine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline N,N-Dimethylglycine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Ornithine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Phenylalanine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Proline concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Sarcosine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Threonine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Tyrosine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Valine concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline 2-Hydroxybutyric acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Acetic acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Citric acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Formic acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Lactic acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Succinic acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Choline concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline 2-Oxoglutaric acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline 3-Hydroxybutyric acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Acetoacetic acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Acetone concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Pyruvic acid concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline D-Galactose concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Glucose concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Glycerol concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • Baseline Dimethylsulfone concentration (mmol/L)

    Determined from NMR analysis of blood plasma

    In the morning immediately after the Control night

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (5)

  • Cardiovascular activation in response to noise

    Event-related, occurring within the time window of each discrete noise event, during each of the five study nights (23:00 to 07:00)

  • Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale

    Every study evening

  • Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale

    Every study morning

  • Evening auditory fatigue

    Every study evening

  • Morning auditory fatigue

    Every study morning

Study Arms (4)

Control

NO INTERVENTION

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

Traffic noise

EXPERIMENTAL

Single study night with traffic noise events, to determine consequences of sleep disturbance by traffic noise

Radiation: Traffic noise

Pink noise

EXPERIMENTAL

Single study night to measure the effects of a non-pharmacological intervention to promote sleep, pink noise.

Radiation: Pink noise exposure

Traffic noise + pink noise

EXPERIMENTAL

Single study night with concurrent traffic noise events and continuous pink noise sound exposure. Night is used to determine attenuation of sleep disturbance by traffic noise due to introduction of pink noise.

Radiation: Pink noise exposureRadiation: Traffic noise

Interventions

Pink noise exposureRADIATION

Continuous pink noise sound exposure at 45 dBA, throughout the whole night

Pink noiseTraffic noise + pink noise
Traffic noiseRADIATION

120 traffic noise events (40 each of road, rail and aircraft), introduced at maximum sound pressure levels ranging between 45-65 dB LAS.max.

Traffic noiseTraffic noise + pink noise

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;
  • pre-existing use of "white noise machines" as a sleep aid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, Västra Götaland County, 42650, Sweden

Location

Related Publications (1)

  • Vincens N, Nause A, Basner M, Fredriksson S, Malmodin D, Bay Nord A, Persson Waye K, Younes M, Zou D, Smith MG. Pink noise reduces impact of traffic noise on sleep and the blood metabolome: a cross-over pilot study. Commun Med (Lond). 2026 Jan 10. doi: 10.1038/s43856-026-01380-5. Online ahead of print.

    PMID: 41513961DERIVED

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 and/or pink 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: All participants will be exposed to each of the different noise exposure conditions. Each study night is treated as a separate arm of the crossover study. 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: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

April 8, 2022

Study Start

April 24, 2022

Primary Completion

June 3, 2022

Study Completion

June 3, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)