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Tech4Rest Trial With Team Truck Drivers (Tech4Rest)

Primary Purpose

Sleep, Sleep Disturbance, Sleep Disorder, Shift Work

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Cab
Fit4Sleep
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep focused on measuring Health Promotion, Injury Prevention, Safety, Wellbeing, Physical Activity, Sleep, Whole Body Vibration, Self-Monitoring

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Health and Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Usual practices with regards to cab conditions and access to workplace programs for preventing sleep and fatigue problems.

Outcomes

Primary Outcome Measures

Change from baseline in actigraphic measures of sleep quality/quantity at 3 and 6 months
Direct measurement via Actigraph GT3x+ BT
Change from baseline in self-reported sleep quality/quantity at 3 and 6 months
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Change from baseline in sleep-related impairment at 3 and 6 months
PROMIS Sleep-Related Impairment (Cella et al., 2010; Yu et al., 2012)
Change from baseline in objectively measured fatigue at 3 and 6 months
Psychomotor Vigilance Task (Dinges & Powell, 1985; Basner & Dinges, 2011)
Change from baseline in self-reported fatigue at 3 and 6 months
Swedish Occupational Fatigue Inventory (Ahsberg, 2000)
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

Secondary Outcome Measures

Change from baseline in actigraphy measures of exercise and sedentary time at 3 and 6 months
Direct measurement via Actigraph GT3x+ BT
Change from baseline in self-reported exercise at 3 and 6 months
Healthy physical activity scale (Elliot et al., 2007)
Change from baseline in self-reported sedentary time at 3 and 6 months
Sedentary Behavior Questionnaire for adults (Rosenberg et al., 2010)
Change from baseline in sleep hygiene practices at 3 and 6 months
Sleep Hygiene Index (Mastin et al., 2006)
Change from baseline in well-being at 3 and 6 months
PROMIS Global Health (Cella et al., 2007, Hays et al., 2009)
Change from baseline in musculoskeletal pain at 3 and 6 months
Adapted Nordic questionnaire for musculoskeletal symptoms (Kuorinka et al., 1987)
Change from baseline in disability due to low back pain at 3 and 6 months
Roland Morris Disability Index (Roland et al., 1983)
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
Change from baseline in driving moving violations at 3 and 6 months
Self-reported and/or company collected data
Change from baseline in driving vehicle collisions at 3 and 6 months
Self-reported and/or company collected data
Change from baseline in body weight at 3 and 6 months
Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer
Change from baseline in percent body fat at 3 and 6 months
Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer
Change from baseline in blood pressure at 3 and 6 months
Direct measurement via Omron HEM-907 automatic blood pressure monitor
Change from baseline in high sugar/fat food and drink consumption at 3 and 6 months
Buxton et al., 2009
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

Full Information

First Posted
March 30, 2017
Last Updated
June 19, 2019
Sponsor
Oregon Health and Science University
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC), Washington State, Department of Labor and Industries, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03108599
Brief Title
Tech4Rest Trial With Team Truck Drivers
Acronym
Tech4Rest
Official Title
Engineering and Behavioral Controls for Truck Drivers' Sleep, Safety, and Health
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC), Washington State, Department of Labor and Industries, University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual practices with regards to cab conditions and access to workplace programs for preventing sleep and fatigue problems.
Intervention Type
Other
Intervention Name(s)
Enhanced Cab
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fit4Sleep
Other Intervention Name(s)
Behavioral Sleep Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in actigraphic measures of sleep quality/quantity at 3 and 6 months
Description
Direct measurement via Actigraph GT3x+ BT
Time Frame
One week samples at Baseline, 3 months, and 6 months
Title
Change from baseline in self-reported sleep quality/quantity at 3 and 6 months
Description
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in sleep-related impairment at 3 and 6 months
Description
PROMIS Sleep-Related Impairment (Cella et al., 2010; Yu et al., 2012)
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in objectively measured fatigue at 3 and 6 months
Description
Psychomotor Vigilance Task (Dinges & Powell, 1985; Basner & Dinges, 2011)
Time Frame
One week samples at Baseline, 3 months, and 6 months
Title
Change from baseline in self-reported fatigue at 3 and 6 months
Description
Swedish Occupational Fatigue Inventory (Ahsberg, 2000)
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in driving performance at 3 and 6 months
Description
Objective truck engine records of fuel efficiency and hard brakes (decelerations >7mph per second) per 10,000 miles driven will be collected from companies
Time Frame
Baseline, 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in actigraphy measures of exercise and sedentary time at 3 and 6 months
Description
Direct measurement via Actigraph GT3x+ BT
Time Frame
One week samples at Baseline, 3 months, and 6 months
Title
Change from baseline in self-reported exercise at 3 and 6 months
Description
Healthy physical activity scale (Elliot et al., 2007)
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in self-reported sedentary time at 3 and 6 months
Description
Sedentary Behavior Questionnaire for adults (Rosenberg et al., 2010)
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in sleep hygiene practices at 3 and 6 months
Description
Sleep Hygiene Index (Mastin et al., 2006)
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in well-being at 3 and 6 months
Description
PROMIS Global Health (Cella et al., 2007, Hays et al., 2009)
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in musculoskeletal pain at 3 and 6 months
Description
Adapted Nordic questionnaire for musculoskeletal symptoms (Kuorinka et al., 1987)
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in disability due to low back pain at 3 and 6 months
Description
Roland Morris Disability Index (Roland et al., 1983)
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in work-related injuries at 3 and 6 months
Description
Self-reported and/or company collected data on worker injuries and lost work days due to injury
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in driving moving violations at 3 and 6 months
Description
Self-reported and/or company collected data
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in driving vehicle collisions at 3 and 6 months
Description
Self-reported and/or company collected data
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in body weight at 3 and 6 months
Description
Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in percent body fat at 3 and 6 months
Description
Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in blood pressure at 3 and 6 months
Description
Direct measurement via Omron HEM-907 automatic blood pressure monitor
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in high sugar/fat food and drink consumption at 3 and 6 months
Description
Buxton et al., 2009
Time Frame
Baseline, 3 months, and 6 months
Title
Change from baseline in fruit and vegetable consumption at 3 and 6 months
Description
Single-item on number of fruit and vegetable servings developed for study
Time Frame
Baseline, 3 months, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Olson, PhD
Phone
503-494-2501
Email
olsonry@ohsu.edu
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Olson, PhD
Phone
503-494-2501
Email
olsonry@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Kelsey Parker, PhD
Phone
5034946580
Email
parkkel@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Ryan Olson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

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Tech4Rest Trial With Team Truck Drivers

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