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Completed

NCT Number: NCT03108599

Tech4Rest Trial With Team Truck Drivers

The current project is a safety and health intervention focused on sleep and fatigue among truck driver teams (pairs), where one driver sleeps in a moving vehicle while the other partner drives. This study is conducted within the Oregon Healthy Workforce Center (OHWC), a NIOSH Center of Excellence in Total Worker Health. We will evaluate engineering and behavioral interventions to improve sleep, reduce fatigue, and impact Total Worker Health. An enhanced cab intervention will alter whole body vibrations during driving and sleep periods, and includes a therapeutic mattress system and an active suspension seat. The enhanced cab will be evaluated alone and in combination with a behavioral sleep intervention adapted from our effective SHIFT (Safety &Health Involvement For Truckers) program. The interventions prioritize hazard reduction according to the hierarchy of controls, and will be evaluated with a randomized controlled design.

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Key information

Conditions

Sleep Behavior Chronobiology Disorders Dyssomnias Fatigue Health Behavior Health Knowledge, Attitudes, Practice Mental Disorders Motor Activity Nervous System Diseases Occupational Diseases Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder, Shift Work Sleep Disorders, Circadian Rhythm Sleep Disturbance Sleep Wake Disorders Vibration; Exposure

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

Total Worker Health® (TWH) is defined as policies, programs, and practices that integrate protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being. Sleep deficiency is a cross-cutting factor for TWH that not only impacts workplace safety, but also generates excess risk for obesity, chronic disease, and early mortality. Long-haul truck drivers average less sleep per night on the road than they do when sleeping at home due to long, irregular work hours and unfavorable sleeping conditions in truck sleeper berths (e.g., low quality mattresses, vibrations, noise, temperature). Sleep deficiency in trucking is a likely contributor to the 69% prevalence of obesity among US drivers, which increases the risk of obstructive sleep apnea and deadly crashes. Despite the severity of these interacting problems, research on engineering controls in commercial truck cabs to improve sleep and reduce fatigue is limited. Behavioral interventions to improve sleep among truck drivers are also limited. We must address these gaps and evaluate the economic cost-utility of interventions to stimulate industry investment in factors that substantially improve drivers' TWH.

The primary goal of this proposal is to evaluate the effects of an enhanced cab intervention on long-haul truck drivers' sleep and TWH with a randomized controlled design. A secondary goal is to evaluate the additive effects of a behavioral sleep intervention. We focus on truck driver teams (pairs), where one driver sleeps in a moving vehicle while the other partner drives, who experience twice as many awakenings as solo drivers. Our enhanced cab intervention will alter whole body vibrations during driving and sleep periods, and includes a therapeutic mattress system with anti-vibration characteristics (Thevorest) and an active suspension seat (BoseRide III). The enhanced cab will be evaluated alone and in combination with a behavioral sleep intervention adapted from our effective SHIFT program. Our preliminary studies show that the therapeutic mattress system alters vibrations and is strongly preferred by drivers, the active suspension seat reduces vibration exposure and fatigue, and that SHIFT produces robust health behavior changes. Our primary hypotheses are that relative to a control group, the enhanced cab intervention will improve objective measures of (a) sleep duration and quality, (b) fatigue, and (c) driver performance. We will also measure impacts on musculoskeletal pain, well-being, and health behaviors (diet, physical activity). We also hypothesize that intervention effects will be larger when combined with a behavioral sleep intervention. Our propensity for success is bolstered by our unique prior accomplishments and strong trucking industry support. To accomplish our goals and test our hypotheses we propose a 5-year project to accomplish 3 specific aims:

  • Pilot test intervention and experimental procedures. We will conduct formative research with dispatchers and driving teams and adapt our SHIFT intervention to focus explicitly on improving sleep. We will then pilot data collection and intervention procedures (enhanced cab and behavioral interventions) with team truck drivers. This preliminary work will guide adjustments prior to our randomized controlled trial.
  • Determine the effectiveness of an enhanced cab intervention alone and in combination with a behavioral sleep intervention for improving truck drivers' sleep, fatigue, and performance. Teams will be randomized into intervention and control groups. Intervention teams will complete 3 phases: baseline, enhanced cab intervention, and enhanced cab intervention + behavioral sleep intervention. Control teams will be measured at the same time points. Primary outcomes will include sleep duration and quality (actigraphy), fatigue (psychomotor vigilance task), and driver performance (fuel efficiency and hard braking events). Secondary outcomes will include musculoskeletal symptoms, well-being, diet, and exercise.
  • Conduct cost-utility analyses for interventions. We will gather historical data from trucking companies and model the cost-utility of intervention components. Model variables will include intervention costs and estimated returns or savings based on intervention effects, such as improvements in driver performance (e.g., fuel efficiency), reduced lost workdays, and reduced probability of fatigue-related crashes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently working as a team truck driver with a driving partner who is also willing to participate.
  • Employed at a company that supports the project requirements

Exclusion criteria

  • Non-treatment compliant for diagnosed Obstructive Sleep Apnea
  • Driving teammate is unwilling, unable, or ineligible to participate

Treatment and study plan

Enhanced Cab

Other

The enhanced cab intervention includes the introduction of an active suspension seat and a therapeutic mattress system. After a baseline phase, the intervention arm will receive the enhanced cab intervention alone, and then the enhanced cab plus a behavioral sleep program.

Fit4Sleep

Behavioral

The behavioral sleep program includes a friendly dyad-based physical activity competition; self-monitoring and logging of physical activity, sleep hygiene behaviors, and sleep; and individual coaching. The behavioral sleep program includes an optional body weight management component. The intervention arm will receive the behavioral sleep program in combination with the enhanced cab intervention.

Other names: Behavioral Sleep Program

Primary outcomes

  1. Change from baseline in self-reported sleep duration in hours at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Pittsburgh Sleep Quality Index sleep duration question (more hours is better sleep duration)

  2. Change from baseline in self-reported sleep duration in hours at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Pittsburgh Sleep Quality Index sleep duration question (more hours is better sleep duration)

  3. Change from baseline in self-reported sleep quality at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Pittsburgh Sleep Quality Index sleep quality question (0-3, higher is better sleep quality)

  4. Change from baseline in self-reported sleep quality at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Pittsburgh Sleep Quality Index sleep quality question (0-3, higher is better sleep quality)

  5. Change from baseline in sleep disturbance at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Sleep Disturbance Scale, Patient-Reported Outcomes Measurement Information System (8-40, higher is worse [greater sleep disturbance])

  6. Change from baseline in sleep-related impairment at 2 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Sleep Disturbance Scale, Patient-Reported Outcomes Measurement Information System (8-40, higher is worse [greater sleep disturbance])

  7. Change from baseline in sleep-related impairment at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Sleep-Related Impairment Scale, Patient-Reported Outcomes Measurement Information System (8-40, higher is worse [greater sleep-related impairment])

  8. Change from baseline in sleep-related impairment at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Sleep-Related Impairment Scale, Patient-Reported Outcomes Measurement Information System (8-40, higher is worse [greater sleep-related impairment])

  9. Change from baseline in self-reported fatigue at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Swedish Occupational Fatigue Inventory (0-48, higher is worse [more fatigue])

  10. Change from baseline in self-reported fatigue at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program

    Swedish Occupational Fatigue Inventory (0-48, higher is worse [more fatigue])

  11. Change from baseline in actigraphic measures of sleep duration in hours at 2 months

    Time frame: One week samples at Baseline and 2 months (post-enhanced cab)

    Direct measurement via Actigraph GT3x+ BT (more hours is better sleep duration)

  12. Change from baseline in actigraphic measures of sleep duration in hours at 3-4 months

    Time frame: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Direct measurement via Actigraph GT3x+ BT (more hours is better sleep duration)

  13. Change from baseline in actigraphic measures of sleep efficiency percentage at 2 months

    Time frame: One week samples at Baseline and 2 months (post-enhanced cab)

    Direct measurement via Actigraph GT3x+ BT (higher percentage is better sleep efficiency)

  14. Change from baseline in actigraphic measures of sleep efficiency percentage at 3-4 months

    Time frame: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Direct measurement via Actigraph GT3x+ BT (higher percentage is better sleep efficiency)

Secondary outcomes

  1. Change from baseline in sleep hygiene practices at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Sleep Hygiene Index (0-48, higher is worse sleep hygiene)

  2. Change from baseline in sleep hygiene practices at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Sleep Hygiene Index (0-48, higher is worse sleep hygiene)

  3. Change from baseline in self-reported days per week with moderate intensity physical activity at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    International Physical Activity Scale-Short Form moderate intensity physical activity question (0-7 days, more days is better moderate physical activity levels)

  4. Change from baseline in self-reported moderate intensity physical activity at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    International Physical Activity Scale-Short Form moderate intensity physical activity question (0-7 days, more days is better moderate physical activity levels)

  5. Change from baseline in self-reported vigorous intensity physical activity at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    International Physical Activity Scale-Short Form vigorous physical activity question (0-7 days, more days is better vigorous intensity physical activity levels)

  6. Change from baseline in self-reported vigorous intensity physical activity at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    International Physical Activity Scale-Short Form vigorous physical activity question (0-7 days, more days is better vigorous intensity physical activity levels)

  7. Change from baseline in actigraphy measures of minutes per week in physical activity bouts at 2 months

    Time frame: One week samples at Baseline and 2 months (post-enhanced cab)

    Direct measurement via Actigraph GT3x+ BT (more minutes is better)

  8. Change from baseline in actigraphy measures of minutes per week in physical activity bouts at 3-4 months

    Time frame: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Direct measurement via Actigraph GT3x+ BT (more minutes is better)

  9. Change from baseline in actigraphy measures of 10-minute physical activity bouts at 2 months

    Time frame: One week samples at Baseline and 2 months (post-enhanced cab)

    Direct measurement via Actigraph GT3x+ BT (more bouts is better)

  10. Change from baseline in actigraphy measures of 10-minute physical activity bouts at 3-4 months

    Time frame: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Direct measurement via Actigraph GT3x+ BT (more bouts is better)

  11. Change from baseline in well-being (physical health) at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Physical Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better physical health)

  12. Change from baseline in well-being (physical health) at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Physical Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better physical health)

  13. Change from baseline in well-being (mental health) at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Mental Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better mental health)

  14. Change from baseline in well-being (mental health) at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Mental Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better mental health)

Other outcomes

  1. Change from baseline in body weight at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer (higher weight is worse)

  2. Change from baseline in body weight at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer (higher weight is worse)

  3. Change from baseline in body mass index at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Direct measurement via stadiometer and Tanita TBF-310GS Bioelectric Impedance Analyzer (higher body mass index is worse)

  4. Change from baseline in body mass index at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Direct measurement via stadiometer and Tanita TBF-310GS Bioelectric Impedance Analyzer (higher body mass index is worse)

  5. Change from baseline in percent body fat at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer (higher percent body fat is worse)

  6. Change from baseline in percent body fat at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer (higher percent body fat is worse)

  7. Change from baseline in systolic blood pressure at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Direct measurement via Omron HEM-907 automatic blood pressure monitor (higher systolic blood pressure is worse)

  8. Change from baseline in systolic blood pressure at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Direct measurement via Omron HEM-907 automatic blood pressure monitor (higher systolic blood pressure is worse)

  9. Change from baseline in diastolic blood pressure at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Direct measurement via Omron HEM-907 automatic blood pressure monitor (higher diastolic blood pressure is worse)

  10. Change from baseline in diastolic blood pressure at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Direct measurement via Omron HEM-907 automatic blood pressure monitor (higher diastolic blood pressure is worse)

  11. Change from baseline in fruit and vegetable servings per day at 2 months

    Time frame: Baseline and 2 months (post-enhanced cabs)

    Single-item on number of fruit and vegetable servings developed by investigators (0-5+, more servings is better)

  12. Change from baseline in fruit and vegetable servings per day at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Single-item on number of fruit and vegetable servings developed by investigators (0-5+, more servings is better)

  13. Change from baseline in frequency of meals brought from home at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)

  14. Change from baseline in frequency of meals brought from home at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)

  15. Change from baseline in frequency of consumption of sugary snacks at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)

  16. Change from baseline in frequency of consumption of sugary snacks at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)

  17. Change from baseline in frequency of sugary drink consumption at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)

  18. Change from baseline in frequency of sugary drink consumption at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program

    single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)

  19. Change from baseline in frequency of fast food consumption at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)

  20. Change from baseline in frequency of fast food consumption at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)

  21. Change from baseline in pain interference with home and work activities at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Adapted Nordic-style questionnaire for musculoskeletal symptoms (5-25, higher is worse [greater pain interference])

  22. Change from baseline in pain interference with home and work activities at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Adapted Nordic-style questionnaire for musculoskeletal symptoms (5-25, higher is worse [greater pain interference])

  23. Change from baseline in pain intensity at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Adapted Nordic-style questionnaire for musculoskeletal symptoms (0-50, higher is worse pain)

  24. Change from baseline in pain intensity at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Adapted Nordic-style questionnaire for musculoskeletal symptoms (0-50, higher is worse pain)

  25. Change from baseline in driving vehicle collisions without damage at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Self-reported vehicle collisions without damage using item created by investigators (0-5+, more is worse)

  26. Change from baseline in driving vehicle collisions without damage at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Self-reported vehicle collisions without damage using item created by investigators (0-5+, more is worse)

  27. Change from baseline in driving vehicle collisions with damage at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Self-reported vehicle collisions with damage using two items created by investigators (0-5+, more is worse)

  28. Change from baseline in driving vehicle collisions with damage at 2 and 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Self-reported vehicle collisions with damage using two items created by investigators (0-5+, more is worse)

  29. Change from baseline in minor injuries at work at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Self-reported worker injuries without lost work time using item created by investigators (0-5+, more is worse)

  30. Change from baseline in minor injuries at work at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Self-reported worker injuries without lost work time using item created by investigators (0-5+, more is worse)

  31. Change from baseline in major injuries at work at 2 months

    Time frame: Baseline and 2 months (post-enhanced cab)

    Self-reported worker injuries resulting in lost work time using item created by investigators (0-5+, more is worse)

  32. Change from baseline in major injuries at work at 3-4 months

    Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

    Self-reported worker injuries resulting in lost work time using item created by investigators (0-5+, more is worse)

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute for Occupational Safety and Health (NIOSH/CDC)
  • University of Washington
  • Washington State, Department of Labor and Industries

Registry information

Official study title

Engineering and Behavioral Controls for Truck Drivers' Sleep, Safety, and Health

Acronym: Tech4Rest

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 11, 2017
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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