Low Particle Emission and Low Noise Tyres
Condition: Noise Exposure; Sleep Disturbance; Sleep Hygiene; Metabolic Disturbance; Cognitive Change
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

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.
    

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.
    

Intervention name(s): Tyre noise - continuous flow; Tyre noise - discrete events; High noise level; Moderate noise level; Low noise level; Air-filled tyres; Composite tyres
Intervention type(s): Radiation; Radiation; Radiation; Radiation; Radiation; Radiation; Radiation
Intervention description(s): Tyre noise from continuous traffic, throughout the night; Tyre noise from few, discrete traffic events, occurring throughout the night; Tyre noise corresponding up to 65 dB LAEq,24h; Tyre noise corresponding up to 60 dB LAEq,24h; Tyre noise corresponding up to 55 dB LAEq,24h; Tyre noise from traditional, air-filled tyres; Tyre noise from newly designed, airless composite tyres
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.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Neurobehavioural Performance; Polysomnography; Metabolomics