Tech4Rest Trial With Team Truck Drivers

Fatigue Clinical Trial

— Tech4Rest  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03108599
• Other study ID #: 15440
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: September 2021

Study information

• Verified date: June 2019
• Source: Oregon Health and Science University
• Contact: Ryan Olson, PhD
• Phone: 503-494-2501
• Email: olsonry[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Fatigue
• Health Behavior
• Health Knowledge, Attitudes, Practice
• Parasomnias
• Sleep
• Sleep Disorder, Shift Work
• Sleep Disorders, Circadian Rhythm
• Sleep Disturbance
• Sleep Wake Disorders
• Vibration; Exposure

Intervention

Other:
• Enhanced Cab
The cab engineering 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 intervention.

Behavioral:
• Fit4Sleep
The behavioral sleep intervention includes a friendly dyad-based physical activity competition; self-monitoring and logging of physical activity, sleep hygiene behaviors, and sleep; and individual coaching. The intervention arm will receive the behavioral sleep intervention in combination with the enhanced cab intervention.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute for Occupational Safety and Health (NIOSH/CDC), University of Washington, Washington State, Department of Labor and Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in actigraphic measures of sleep quality/quantity at 3 and 6 months	Direct measurement via Actigraph GT3x+ BT	One week samples at Baseline, 3 months, and 6 months
Primary	Change from baseline in self-reported sleep quality/quantity at 3 and 6 months	Pittsburgh Sleep Quality Index (Buysse et al., 1989)	Baseline, 3 months, and 6 months
Primary	Change from baseline in sleep-related impairment at 3 and 6 months	PROMIS Sleep-Related Impairment (Cella et al., 2010; Yu et al., 2012)	Baseline, 3 months, and 6 months
Primary	Change from baseline in objectively measured fatigue at 3 and 6 months	Psychomotor Vigilance Task (Dinges & Powell, 1985; Basner & Dinges, 2011)	One week samples at Baseline, 3 months, and 6 months
Primary	Change from baseline in self-reported fatigue at 3 and 6 months	Swedish Occupational Fatigue Inventory (Ahsberg, 2000)	Baseline, 3 months, and 6 months
Primary	Change from baseline in driving performance at 3 and 6 months	Objective truck engine records of fuel efficiency and hard brakes (decelerations >7mph per second) per 10,000 miles driven will be collected from companies	Baseline, 3 months, and 6 months
Secondary	Change from baseline in actigraphy measures of exercise and sedentary time at 3 and 6 months	Direct measurement via Actigraph GT3x+ BT	One week samples at Baseline, 3 months, and 6 months
Secondary	Change from baseline in self-reported exercise at 3 and 6 months	Healthy physical activity scale (Elliot et al., 2007)	Baseline, 3 months, and 6 months
Secondary	Change from baseline in self-reported sedentary time at 3 and 6 months	Sedentary Behavior Questionnaire for adults (Rosenberg et al., 2010)	Baseline, 3 months, and 6 months
Secondary	Change from baseline in sleep hygiene practices at 3 and 6 months	Sleep Hygiene Index (Mastin et al., 2006)	Baseline, 3 months, and 6 months
Secondary	Change from baseline in well-being at 3 and 6 months	PROMIS Global Health (Cella et al., 2007, Hays et al., 2009)	Baseline, 3 months, and 6 months
Secondary	Change from baseline in musculoskeletal pain at 3 and 6 months	Adapted Nordic questionnaire for musculoskeletal symptoms (Kuorinka et al., 1987)	Baseline, 3 months, and 6 months
Secondary	Change from baseline in disability due to low back pain at 3 and 6 months	Roland Morris Disability Index (Roland et al., 1983)	Baseline, 3 months, and 6 months
Secondary	Change from baseline in work-related injuries at 3 and 6 months	Self-reported and/or company collected data on worker injuries and lost work days due to injury	Baseline, 3 months, and 6 months
Secondary	Change from baseline in driving moving violations at 3 and 6 months	Self-reported and/or company collected data	Baseline, 3 months, and 6 months
Secondary	Change from baseline in driving vehicle collisions at 3 and 6 months	Self-reported and/or company collected data	Baseline, 3 months, and 6 months
Secondary	Change from baseline in body weight at 3 and 6 months	Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer	Baseline, 3 months, and 6 months
Secondary	Change from baseline in percent body fat at 3 and 6 months	Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer	Baseline, 3 months, and 6 months
Secondary	Change from baseline in blood pressure at 3 and 6 months	Direct measurement via Omron HEM-907 automatic blood pressure monitor	Baseline, 3 months, and 6 months
Secondary	Change from baseline in high sugar/fat food and drink consumption at 3 and 6 months	Buxton et al., 2009	Baseline, 3 months, and 6 months
Secondary	Change from baseline in fruit and vegetable consumption at 3 and 6 months	Single-item on number of fruit and vegetable servings developed for study	Baseline, 3 months, and 6 months