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Tech4Rest Trial With Team Truck Drivers (Tech4Rest)

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ClinicalTrials.gov Identifier: NCT03108599
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
National Institute for Occupational Safety and Health (NIOSH/CDC)
Washington State, Department of Labor and Industries
University of Washington
Information provided by (Responsible Party):
Ryan Olson, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Sleep Sleep Disturbance Sleep Disorder, Shift Work Health Knowledge, Attitudes, Practice Health Behavior Fatigue Vibration; Exposure Other: Enhanced Cab Behavioral: Fit4Sleep Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In the RCT, participants will be randomly assigned to either the control or intervention groups. Following a baseline period, intervention participants will receive the cab engineering portion of the intervention on its own. Then, for the following intervention phase, intervention participants will participate in the behavioral sleep intervention in addition to continuing the cab engineering intervention.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Engineering and Behavioral Controls for Truck Drivers' Sleep, Safety, and Health
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Intervention
All participants in the intervention arm will receive two interventions: an enhanced cab intervention alone, and then the enhanced cab conditions combined with a behavioral sleep 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.
Other Name: Behavioral Sleep Intervention

No Intervention: Control
Usual practices with regards to cab conditions and access to workplace programs for preventing sleep and fatigue problems.



Primary Outcome Measures :
  1. Change from baseline in actigraphic measures of sleep quality/quantity at 3 and 6 months [ Time Frame: One week samples at Baseline, 3 months, and 6 months ]
    Direct measurement via Actigraph GT3x+ BT

  2. Change from baseline in self-reported sleep quality/quantity at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Pittsburgh Sleep Quality Index (Buysse et al., 1989)

  3. Change from baseline in sleep-related impairment at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    PROMIS Sleep-Related Impairment (Cella et al., 2010; Yu et al., 2012)

  4. Change from baseline in objectively measured fatigue at 3 and 6 months [ Time Frame: One week samples at Baseline, 3 months, and 6 months ]
    Psychomotor Vigilance Task (Dinges & Powell, 1985; Basner & Dinges, 2011)

  5. Change from baseline in self-reported fatigue at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Swedish Occupational Fatigue Inventory (Ahsberg, 2000)

  6. Change from baseline in driving performance at 3 and 6 months [ Time Frame: Baseline, 3 months, 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


Secondary Outcome Measures :
  1. Change from baseline in actigraphy measures of exercise and sedentary time at 3 and 6 months [ Time Frame: One week samples at Baseline, 3 months, and 6 months ]
    Direct measurement via Actigraph GT3x+ BT

  2. Change from baseline in self-reported exercise at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Healthy physical activity scale (Elliot et al., 2007)

  3. Change from baseline in self-reported sedentary time at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Sedentary Behavior Questionnaire for adults (Rosenberg et al., 2010)

  4. Change from baseline in sleep hygiene practices at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Sleep Hygiene Index (Mastin et al., 2006)

  5. Change from baseline in well-being at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    PROMIS Global Health (Cella et al., 2007, Hays et al., 2009)

  6. Change from baseline in musculoskeletal pain at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Adapted Nordic questionnaire for musculoskeletal symptoms (Kuorinka et al., 1987)

  7. Change from baseline in disability due to low back pain at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Roland Morris Disability Index (Roland et al., 1983)

  8. Change from baseline in work-related injuries at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Self-reported and/or company collected data on worker injuries and lost work days due to injury

  9. Change from baseline in driving moving violations at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Self-reported and/or company collected data

  10. Change from baseline in driving vehicle collisions at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Self-reported and/or company collected data

  11. Change from baseline in body weight at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer

  12. Change from baseline in percent body fat at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer

  13. Change from baseline in blood pressure at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Direct measurement via Omron HEM-907 automatic blood pressure monitor

  14. Change from baseline in high sugar/fat food and drink consumption at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Buxton et al., 2009

  15. Change from baseline in fruit and vegetable consumption at 3 and 6 months [ Time Frame: Baseline, 3 months, and 6 months ]
    Single-item on number of fruit and vegetable servings developed for study



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108599


Contacts
Contact: Ryan Olson, PhD 503-494-2501 olsonry@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Ryan Olson, PhD    503-494-2501    olsonry@ohsu.edu   
Contact: Kelsey Parker, PhD    5034946580    parkkel@ohsu.edu   
Principal Investigator: Ryan Olson, PhD         
Sponsors and Collaborators
Oregon Health and Science University
National Institute for Occupational Safety and Health (NIOSH/CDC)
Washington State, Department of Labor and Industries
University of Washington

Responsible Party: Ryan Olson, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03108599     History of Changes
Other Study ID Numbers: 15440
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only de-identified data will be shared with researchers outside of the primary research team. De-identified data will be shared only after receiving IRB approval.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ryan Olson, Oregon Health and Science University:
Health Promotion
Injury Prevention
Safety
Wellbeing
Physical Activity
Sleep
Whole Body Vibration
Self-Monitoring

Additional relevant MeSH terms:
Fatigue
Sleep Wake Disorders
Parasomnias
Dyssomnias
Sleep Disorders, Circadian Rhythm
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Chronobiology Disorders
Occupational Diseases