LEON-T: Low Particle Emission and Low Noise Tyres

Sponsor
Göteborg University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05611619
Collaborator
University of Pennsylvania (Other), University of Manitoba (Other), Swedish National Road and Transport Research Institute (Other)
45
1
9
23
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Tyre noise - continuous flow
  • Radiation: Tyre noise - discrete events
  • Radiation: High noise level
  • Radiation: Moderate noise level
  • Radiation: Low noise level
  • Radiation: Air-filled tyres
  • Radiation: Composite tyres
N/A

Detailed Description

The experimental sleep study has the overarching goal of deepening our understanding of sleep disruption by automotive tyre noise and changes in cardiometabolic and cognitive function. To this end, the study will address the following independent aims:

Aim 1: Determine the biological and neurobehavioural consequences of sleep disruption by tyre noise. The investigators will measure the sleep of healthy volunteers, and each morning the investigators will obtain blood samples for metabolomics analysis and administer a neurocognitive test battery. The investigators will compare effects on sleep, metabolomics and cognitive function between quiet nights and nights with road traffic noise.

Aim 2: Identify acoustical characteristics of tyre noise that are especially disturbing physiologically. The investigators will use different combinations of types of tyre noise in different noise exposure nights to determine differential effects on sleep and cardiovascular response.

This study will take place in the sound environment laboratory (SEL) at the University of Gothenburg Department of Occupational and Environmental Medicine (Arbets- och miljömedicin [AMM]). The SEL is a high fidelity research laboratory equipped to simulate a typical apartment, including three individually light-, sound- and vibration-isolated private bedrooms. Ceiling mounted speakers in each room allow the investigators to create a realistic acoustic environment by transmitting sound exposures from the control room to each bedroom individually. The investigators have shown previously that results from this lab with high ecological validity are comparable with results from the field.

There will be two study arms, each one affording the opportunity to investigate different acoustical characteristics of tyre noise and their physiological effects. Each of these study arms has a prospective within-subjects cross-over design. Participants (study 1 N=15; study 2 N=30; total N=45 across both arms) will each spend six consecutive nights in the SEL, with a sleep opportunity between 23:00-07:00. Daytime sleep will be prohibited, confirmed with measures of daytime activity via wrist actigraphy monitors worn continuously throughout the study. Three subjects will take part concurrently, in separate bedrooms. The first night is a habituation period to the study protocol and for familiarisation with the test procedures. Study nights 2-6 are the experimental nights and will be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to each of the following:

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 the investigators can examine each combination of two specific noise characteristics.

Each night the investigators will record physiologic sleep with polysomnography (PSG) and cardiac activity with electrocardiography (ECG). Each study morning, subjects will provide a 4 ml blood sample, complete cognitive testing and answer questionnaires and will depart the SEL to follow their normal daytime routine. They will return to the SEL at 20:00 each evening to prepare for sleep measurements. Caffeine will be prohibited after 15:00 and alcohol will be prohibited at all times. Because extreme and/or variable dietary behaviour can affect the metabolome/lipoprotein profile, participants will be given guidance that they should eat a similar evening meal on each day of the laboratory study, confirmed with a food diary, The actual meal itself can be different for different study participants, because the study has a within-subjects design.

Sleep will be recorded with ambulatory polysomnography (PSG) and cardiac activity with electrocardiography (ECG) and finger pulse photoplethysmogram. Data are recorded offline onto the sleep recorder, and will be downloaded and checked every study morning to ensure data quality. In addition to traditional sleep analysis performed by the research group at the University of Gothenburg, raw PSG data will be used to calculate the Odds Ratio Project, a novel metric of sleep depth and stability.

Each study morning subjects will provide a 4 ml blood sample for plasma metabolomics analysis. To ensure reliable data, blood samples will be taken at the same time every day to mitigate circadian effects, before eating or drinking anything except water, and each sample will be handled in the same way i.e. centrifuged, aliquoted and stored in -80C freezers. Subjects will eat the same food each study evening to mitigate within-subject dietary effects on the blood metabolome.

Each morning, subjects will complete a computerised cognitive test battery taking approximately 20 minutes, that includes 10 tests across a range of cognitive domains (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance). Cognition data will be analysed to determine key measures of cognitive speed and accuracy, adjusting for practice effects and the difficulty of the stimulus set.

Subjects will complete a battery of one-time validated questionnaires to measure their general health (SF-36), chronotype, noise sensitivity, habitual sleep quality, environmental sensitivity, and annoyance and sleep disturbance by noise. Subjects will also answer a questionnaire each study evening and morning, involving questions on sleepiness (Karolinska Sleepiness Scale), sleep disturbance by noise, positive and negative affect (PANAS), and validated sleep and disturbance questions.

Participants will wear a wrist actigraphy monitor continuously throughout the study period, and also for the week before the study, to confirm habitual sleep-wake times and to measure physical activity levels.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Basic Science
Official Title:
Low Particle Emission and Low Noise Tyres
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

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

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

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 flow
Tyre noise from continuous traffic, throughout the night

Radiation: High noise level
Tyre noise corresponding up to 65 dB LAEq,24h

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

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 flow
Tyre noise from continuous traffic, throughout the night

Radiation: Moderate noise level
Tyre noise corresponding up to 60 dB LAEq,24h

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

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

Radiation: High noise level
Tyre noise corresponding up to 65 dB LAEq,24h

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

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

Radiation: Moderate noise level
Tyre noise corresponding up to 60 dB LAEq,24h

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

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 level
Tyre noise corresponding up to 60 dB LAEq,24h

Radiation: Composite tyres
Tyre noise from newly designed, airless composite tyres

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

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 level
Tyre noise corresponding up to 55 dB LAEq,24h

Radiation: Composite tyres
Tyre noise from newly designed, airless composite tyres

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

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 level
Tyre noise corresponding up to 60 dB LAEq,24h

Radiation: Air-filled tyres
Tyre noise from traditional, air-filled tyres

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

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 level
Tyre noise corresponding up to 55 dB LAEq,24h

Radiation: Air-filled tyres
Tyre noise from traditional, air-filled tyres

Outcome Measures

Primary Outcome Measures

  1. Baseline total sleep time during the Control night [One night]

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

  2. Baseline total sleep time during the A1 night [One night]

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

  3. Baseline total sleep time during the A2 night [One night]

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

  4. Baseline total sleep time during the B1 night [One night]

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

  5. Baseline total sleep time during the B2 night [One night]

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

  6. Total sleep time during exposure to nocturnal tyre noise combination A1 [One night]

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

  7. Total sleep time during exposure to nocturnal tyre noise combination A2 [One night]

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

  8. Total sleep time during exposure to nocturnal tyre noise combination B1 [One night]

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

  9. Total sleep time during exposure to nocturnal tyre noise combination B2 [One night]

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

  10. Total amount of baseline N1 sleep during the Control night [One night]

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

  11. Total amount of baseline N2 sleep during the Control night [One night]

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

  12. Total amount of baseline N3 sleep during the Control night [One night]

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

  13. Total amount of baseline rapid eye movement (REM) sleep during the Control night [One night]

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

  14. Total amount of N1 sleep during exposure to nocturnal tyre noise combination A1 [One night]

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

  15. Total amount of N2 sleep during exposure to nocturnal tyre noise combination A1 [One night]

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

  16. Total amount of N3 sleep during exposure to nocturnal tyre noise combination A1 [One night]

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

  17. Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A1 [One night]

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

  18. Total amount of N1 sleep during exposure to nocturnal tyre noise combination A2 [One night]

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

  19. Total amount of N2 sleep during exposure to nocturnal tyre noise combination A2 [One night]

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

  20. Total amount of N3 sleep during exposure to nocturnal tyre noise combination A2 [One night]

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

  21. Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination A2 [One night]

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

  22. Total amount of N1 sleep during exposure to nocturnal tyre noise combination B1 [One night]

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

  23. Total amount of N2 sleep during exposure to nocturnal tyre noise combination B1 [One night]

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

  24. Total amount of N3 sleep during exposure to nocturnal tyre noise combination B1 [One night]

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

  25. Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B1 [One night]

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

  26. Total amount of N1 sleep during exposure to nocturnal tyre noise combination B2 [One night]

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

  27. Total amount of N2 sleep during exposure to nocturnal tyre noise combination B2 [One night]

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

  28. Total amount of N3 sleep during exposure to nocturnal tyre noise combination B2 [One night]

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

  29. Total amount of rapid eye movement (REM) sleep during exposure to nocturnal tyre noise combination B2 [One night]

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

  30. Baseline wakefulness after sleep onset (WASO) during the Control night [One night]

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

  31. Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A1 [One night]

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

  32. Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination A2 [One night]

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

  33. Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B1 [One night]

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

  34. Wakefulness after sleep onset (WASO) during exposure to nocturnal tyre noise combination B2 [One night]

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

  35. Baseline number of awakenings during the Control night [One night]

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

  36. Number of awakenings during exposure to nocturnal tyre noise combination A1 [One night]

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

  37. Number of awakenings during exposure to nocturnal tyre noise combination A2 [One night]

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

  38. Number of awakenings during exposure to nocturnal tyre noise combination B1 [One night]

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

  39. Number of awakenings during exposure to nocturnal tyre noise combination B2 [One night]

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

  40. Baseline sleep onset latency (SOL) during the Control night [One night]

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

  41. Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A1 [One night]

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

  42. Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination A2 [One night]

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

  43. Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B1 [One night]

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

  44. Sleep onset latency (SOL) during exposure to nocturnal tyre noise combination B2 [One night]

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

  45. Baseline sleep efficiency during the Control night [One night]

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

  46. Sleep efficiency during exposure to nocturnal tyre noise combination A1 [One night]

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

  47. Sleep efficiency during exposure to nocturnal tyre noise combination A2 [One night]

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

  48. Sleep efficiency during exposure to nocturnal tyre noise combination B1 [One night]

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

  49. Sleep efficiency during exposure to nocturnal tyre noise combination B2 [One night]

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

  50. Baseline sleep depth assessed using the odds ratio product (ORP) during the Control night [One night]

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

  51. Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A1 [One night]

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

  52. Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination A2 [One night]

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

  53. Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B1 [One night]

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

  54. Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal tyre noise combination B2 [One night]

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

  55. Spontaneous maximal change of odds ratio product (ORP) during the Control night [One night]

    Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over 120 sham noise events during the night.

  56. Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A1 [One night]

    Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.

  57. Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination A2 [One night]

    Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.

  58. Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B1 [One night]

    Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.

  59. Maximal change of odds ratio product (ORP) during exposure to tyre noise events combination B2 [One night]

    Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.

  60. Morning neurobehavioural speed in the morning immediately after the Control night [One night]

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

  61. Morning neurobehavioural speed in the morning immediately after the A1 night [One night]

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

  62. Morning neurobehavioural speed in the morning immediately after the A2 night [One night]

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

  63. Morning neurobehavioural speed in the morning immediately after the B1 night [One night]

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

  64. Morning neurobehavioural speed in the morning immediately after the B2 night [One night]

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

  65. Morning neurobehavioural accuracy in the morning after the control night [One night]

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

  66. Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A1 [One night]

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

  67. Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination A2 [One night]

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

  68. Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B1 [One night]

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

  69. Morning neurobehavioural accuracy in the morning after exposure to nocturnal tyre noise combination B2 [One night]

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

  70. Baseline evening neurobehavioural speed following the Control night [One night]

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

  71. Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A1 [One night]

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

  72. Evening neurobehavioural speed after exposure to nocturnal tyre noise combination A2 [One night]

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

  73. Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B1 [One night]

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

  74. Evening neurobehavioural speed after exposure to nocturnal tyre noise combination B2 [One night]

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

  75. Baseline evening neurobehavioural accuracy following the Control night [One night]

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

  76. Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A1 [One night]

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

  77. Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination A2 [One night]

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

  78. Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B1 [One night]

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

  79. Evening neurobehavioural accuracy after exposure to nocturnal tyre noise combination B2 [One night]

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

  80. Event-related Cardiovascular activation in response to noise during Control night [One night]

    Change in heart rate (ECG)

  81. Event-related Cardiovascular activation in response to noise during A1 [One night]

    Change in heart rate (ECG)

  82. Event-related Cardiovascular activation in response to noise during A2 [One night]

    Change in heart rate (ECG)

  83. Event-related Cardiovascular activation in response to noise during B1 [One night]

    Change in heart rate (ECG)

  84. Event-related Cardiovascular activation in response to noise during B2 [One night]

    Change in heart rate (ECG)

  85. Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the control night [One night]

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

  86. Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A1 night [One night]

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

  87. Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the A2 night [One night]

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

  88. Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B1 night [One night]

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

  89. Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale on the B2 night [One night]

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

  90. Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the control night [One night]

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

  91. Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A1 night [One night]

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

  92. Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the A2 night [One night]

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

  93. Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B1 night [One night]

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

  94. Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after the B2 night [One night]

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

  95. Taurine concentration (mmol/L) immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  96. Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  97. Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  98. Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  99. Taurine concentration (mmol/L) in the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  100. Serotonin concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  101. Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  102. Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  103. Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  104. Serotonin concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  105. Tryptophan concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  106. Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  107. Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  108. Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  109. Tryptophan concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  110. Isoleucine concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  111. Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  112. Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  113. Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  114. Isoleucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  115. Baseline Leucine concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  116. Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  117. Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  118. Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  119. Leucine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  120. Baseline Valine concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  121. Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  122. Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  123. Valine concentration (mmol/L)In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  124. Valine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  125. Baseline Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  126. Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  127. Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  128. Diacylglycerol (36:3) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  129. Diacylglycerol (36:3) concentration (mmol/L)In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  130. Baseline Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  131. Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  132. Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  133. Lauroylcarnitine (C12:0) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  134. Lauroylcarnitine (C12:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  135. Baseline Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  136. Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  137. Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  138. Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  139. Octanoylcarnitine (C8:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  140. Baseline Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  141. Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  142. Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  143. Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  144. Myristoylcarnitine (C14:0) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  145. Baseline 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  146. 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  147. 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  148. 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L)In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  149. 1-Methyl-4-pyridone-5-carboxamide (4-Pyr) concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  150. Baseline Phenylalanine concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  151. Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  152. Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  153. Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  154. Phenylalanine concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  155. Baseline Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  156. Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  157. Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  158. Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  159. Acylcarnitine C18:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  160. Baseline Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  161. Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  162. Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  163. Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  164. Acylcarnitine C10:0 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  165. Baseline Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  166. Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  167. Phosphatidylcholine 32:1 concentration (mmol/L)In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  168. Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  169. Phosphatidylcholine 32:1 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  170. Basline Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  171. Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  172. Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  173. Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  174. Phosphatidylcholine 38:2 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

  175. Baseline Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Control night [One night]

    Determined from GC-MS analysis of blood plasma

  176. Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A1 [One night]

    Determined from GC-MS analysis of blood plasma

  177. Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination A2 [One night]

    Determined from GC-MS analysis of blood plasma

  178. Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B1 [One night]

    Determined from GC-MS analysis of blood plasma

  179. Phosphatidylcholine 38:3 concentration (mmol/L) In the morning immediately after the Tyre noise combination B2 [One night]

    Determined from GC-MS analysis of blood plasma

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. live in or around the city of Gothenburg area (Sweden)
Exclusion Criteria:
  1. aged <18 or >30 years;

  2. habitual sleep and wake timings more than ±1 hour different from the study sleep times (i.e. habitual sleep time should be 22:00-00:00 and habitual wake time should be 06:00-08:00);

  3. BMI>25 kg/m2;

  4. regular sleep medication use (prescribed or "over-the-counter");

  5. poor hearing acuity (measured during screening via pure tone audiometry);

  6. diagnosed with sleep disorders;

  7. indications of sleep apnea on the STOP-BANG questionnaire;

  8. shift work;

  9. smoking, vaping, snus, or other nicotine use.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Gothenburg Gothenburg Västra Götaland Sweden 42650

Sponsors and Collaborators

  • Göteborg University
  • University of Pennsylvania
  • University of Manitoba
  • Swedish National Road and Transport Research Institute

Investigators

  • Principal Investigator: Michael G Smith, PhD, Göteborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Göteborg University
ClinicalTrials.gov Identifier:
NCT05611619
Other Study ID Numbers:
  • 254066204
First Posted:
Nov 10, 2022
Last Update Posted:
Nov 10, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Göteborg University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2022