Clinical trial NCT03108599: Tech4Rest Trial With Team Truck Drivers
Official title: Engineering and Behavioral Controls for Truck Drivers' Sleep, Safety, and Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Sleep Disturbance
Sleep Disorder, Shift Work
Health Knowledge, Attitudes, Practice
Health Behavior
Fatigue
Vibration; Exposure
Keywords: Health Promotion
Injury Prevention
Safety
Wellbeing
Physical Activity
Sleep
Whole Body Vibration
Self-Monitoring
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
name: Washington State, Department of Labor and Industries
name: University of Washington
First posted: 2017-04-11
Enrollment: 49
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the randomized controlled trial, participants will be randomly assigned to either the control or intervention groups. Following a baseline period, intervention participants will receive the enhanced cab portion of the intervention on its own. Then, for the following intervention phase, intervention participants will participate in the behavioral sleep program in addition to continuing the enhanced cab intervention.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in self-reported sleep duration in hours at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in self-reported sleep duration in hours at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in self-reported sleep quality at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in self-reported sleep quality at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in sleep disturbance at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in sleep-related impairment at 2 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in sleep-related impairment at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in sleep-related impairment at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in self-reported fatigue at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in self-reported fatigue at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program
measure: Change from baseline in actigraphic measures of sleep duration in hours at 2 months
timeFrame: One week samples at Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in actigraphic measures of sleep duration in hours at 3-4 months
timeFrame: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in actigraphic measures of sleep efficiency percentage at 2 months
timeFrame: One week samples at Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in actigraphic measures of sleep efficiency percentage at 3-4 months
timeFrame: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Secondary outcomes:
measure: Change from baseline in sleep hygiene practices at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in sleep hygiene practices at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in self-reported days per week with moderate intensity physical activity at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in self-reported moderate intensity physical activity at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in self-reported vigorous intensity physical activity at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in self-reported vigorous intensity physical activity at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in actigraphy measures of minutes per week in physical activity bouts at 2 months
timeFrame: One week samples at Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in actigraphy measures of minutes per week in physical activity bouts at 3-4 months
timeFrame: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in actigraphy measures of 10-minute physical activity bouts at 2 months
timeFrame: One week samples at Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in actigraphy measures of 10-minute physical activity bouts at 3-4 months
timeFrame: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in well-being (physical health) at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in well-being (physical health) at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in well-being (mental health) at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in well-being (mental health) at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Other outcomes:
measure: Change from baseline in body weight at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in body weight at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in body mass index at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in body mass index at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in percent body fat at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in percent body fat at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in systolic blood pressure at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in systolic blood pressure at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in diastolic blood pressure at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in diastolic blood pressure at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in fruit and vegetable servings per day at 2 months
timeFrame: Baseline and 2 months (post-enhanced cabs)
measure: Change from baseline in fruit and vegetable servings per day at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in frequency of meals brought from home at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in frequency of meals brought from home at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in frequency of consumption of sugary snacks at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in frequency of consumption of sugary snacks at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in frequency of sugary drink consumption at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in frequency of sugary drink consumption at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program
measure: Change from baseline in frequency of fast food consumption at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in frequency of fast food consumption at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in pain interference with home and work activities at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in pain interference with home and work activities at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in pain intensity at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in pain intensity at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in driving vehicle collisions without damage at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in driving vehicle collisions without damage at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in driving vehicle collisions with damage at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in driving vehicle collisions with damage at 2 and 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in minor injuries at work at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in minor injuries at work at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
measure: Change from baseline in major injuries at work at 2 months
timeFrame: Baseline and 2 months (post-enhanced cab)
measure: Change from baseline in major injuries at work at 3-4 months
timeFrame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
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