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临床试验/NCT03108599
NCT03108599已完成不适用

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

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
Change from baseline in self-reported sleep duration in hours at 3-4 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

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

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

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

时间窗: 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)

Change from baseline in self-reported fatigue at 2 months

时间窗: Baseline and 2 months (post-enhanced cab)

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

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

时间窗: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program

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

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

时间窗: Baseline and 2 months (post-enhanced cab)

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

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

时间窗: Baseline and 2 months (post-enhanced cab)

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

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

时间窗: One week samples at Baseline and 2 months (post-enhanced cab)

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

Change from baseline in sleep disturbance at 2 months

时间窗: Baseline and 2 months (post-enhanced cab)

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

Change from baseline in sleep-related impairment at 2 months

时间窗: Baseline and 2 months (post-enhanced cab)

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

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

时间窗: 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 \[greater sleep-related impairment\])

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

时间窗: 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)

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

时间窗: 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)

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

时间窗: One week samples at Baseline and 2 months (post-enhanced cab)

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

次要结局

  • Change from baseline in well-being (physical health) at 3-4 months(Baseline and 3-4 months (post-enhanced cab + behavioral sleep program))
  • Change from baseline in sleep hygiene practices at 3-4 months(Baseline and 3-4 months (post-enhanced cab + behavioral sleep program))
  • Change from baseline in self-reported days per week with moderate intensity physical activity at 2 months(Baseline and 2 months (post-enhanced cab))
  • Change from baseline in self-reported moderate intensity physical activity at 3-4 months(Baseline and 3-4 months (post-enhanced cab + behavioral sleep program))
  • Change from baseline in well-being (physical health) at 2 months(Baseline and 2 months (post-enhanced cab))
  • Change from baseline in sleep hygiene practices at 2 months(Baseline and 2 months (post-enhanced cab))
  • Change from baseline in actigraphy measures of 10-minute physical activity bouts at 2 months(One week samples at Baseline and 2 months (post-enhanced cab))
  • Change from baseline in self-reported vigorous intensity physical activity at 2 months(Baseline and 2 months (post-enhanced cab))
  • Change from baseline in actigraphy measures of minutes per week in physical activity bouts at 3-4 months(One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program))
  • Change from baseline in self-reported vigorous intensity physical activity at 3-4 months(Baseline and 3-4 months (post-enhanced cab + behavioral sleep program))
  • Change from baseline in actigraphy measures of minutes per week in physical activity bouts at 2 months(One week samples at Baseline and 2 months (post-enhanced cab))
  • Change from baseline in actigraphy measures of 10-minute physical activity bouts at 3-4 months(One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program))
  • Change from baseline in well-being (mental health) at 2 months(Baseline and 2 months (post-enhanced cab))
  • Change from baseline in well-being (mental health) at 3-4 months(Baseline and 3-4 months (post-enhanced cab + behavioral sleep program))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan Olson

Associate Professor

Oregon Health and Science University

研究点 (2)

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