SleepTech4RestNCT03108599
Tech4Rest Trial With Team Truck Drivers
A study testing Enhanced Cab and Fit4Sleep in people with Sleep and Sleep Disturbance, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Disturbance, Sleep Disorder, Shift Work
- What is being tested?
- Enhanced Cab and Fit4Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-treatment compliant for diagnosed Obstructive Sleep Apnea
- Driving teammate is unwilling, unable, or ineligible to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Engineering and Behavioral Controls for Truck Drivers' Sleep, Safety, and Health
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.
Read the 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.
- Conditions
- Sleep, Sleep Disturbance, Sleep Disorder, Shift Work, Health Knowledge, Attitudes, Practice, Health Behavior, Fatigue
- Being tested
- Enhanced Cab, Fit4Sleep
- Keywords
- Health Promotion, Injury Prevention, Safety, Wellbeing, Physical Activity, Sleep, Whole Body Vibration, Self-Monitoring
- Medical subject headings
- Parasomnias, Sleep Disorders, Circadian Rhythm, Behavior, Health Behavior, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced CabOther
The enhanced cab 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 program.
Fit4SleepBehavioural
Also called Behavioral Sleep Program
The behavioral sleep program includes a friendly dyad-based physical activity competition; self-monitoring and logging of physical activity, sleep hygiene behaviors, and sleep; and individual coaching. The behavioral sleep program includes an optional body weight management component. The intervention arm will receive the behavioral sleep program in combination with the enhanced cab intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Enhanced Cab; Behavioral: Fit4Sleep |
| Control | No intervention | Usual practices with regards to cab conditions and access to workplace programs for preventing sleep and fatigue problems. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in self-reported sleep duration in hours at 2 months
Pittsburgh Sleep Quality Index sleep duration question (more hours is better sleep duration)
Measured: Baseline and 2 months (post-enhanced cab)
Change from baseline in self-reported sleep duration in hours at 3-4 months
Pittsburgh Sleep Quality Index sleep duration question (more hours is better sleep duration)
Measured: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in self-reported sleep quality at 2 months
Pittsburgh Sleep Quality Index sleep quality question (0-3, higher is better sleep quality)
Measured: Baseline and 2 months (post-enhanced cab)
Change from baseline in self-reported sleep quality at 3-4 months
Pittsburgh Sleep Quality Index sleep quality question (0-3, higher is better sleep quality)
Measured: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in sleep disturbance at 2 months
Sleep Disturbance Scale, Patient-Reported Outcomes Measurement Information System (8-40, higher is worse [greater sleep disturbance])
Measured: Baseline and 2 months (post-enhanced cab)
Change from baseline in sleep-related impairment at 2 months
Sleep Disturbance Scale, Patient-Reported Outcomes Measurement Information System (8-40, higher is worse [greater sleep disturbance])
Measured: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in sleep-related impairment at 2 months
Sleep-Related Impairment Scale, Patient-Reported Outcomes Measurement Information System (8-40, higher is worse [greater sleep-related impairment])
Measured: Baseline and 2 months (post-enhanced cab)
Change from baseline in sleep-related impairment at 3-4 months
Sleep-Related Impairment Scale, Patient-Reported Outcomes Measurement Information System (8-40, higher is worse [greater sleep-related impairment])
Measured: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in self-reported fatigue at 2 months
Swedish Occupational Fatigue Inventory (0-48, higher is worse [more fatigue])
Measured: Baseline and 2 months (post-enhanced cab)
Change from baseline in self-reported fatigue at 3-4 months
Swedish Occupational Fatigue Inventory (0-48, higher is worse [more fatigue])
Measured: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program
Change from baseline in actigraphic measures of sleep duration in hours at 2 months
Direct measurement via Actigraph GT3x+ BT (more hours is better sleep duration)
Measured: One week samples at Baseline and 2 months (post-enhanced cab)
Change from baseline in actigraphic measures of sleep duration in hours at 3-4 months
Direct measurement via Actigraph GT3x+ BT (more hours is better sleep duration)
Measured: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in actigraphic measures of sleep efficiency percentage at 2 months
Direct measurement via Actigraph GT3x+ BT (higher percentage is better sleep efficiency)
Measured: One week samples at Baseline and 2 months (post-enhanced cab)
Change from baseline in actigraphic measures of sleep efficiency percentage at 3-4 months
Direct measurement via Actigraph GT3x+ BT (higher percentage is better sleep efficiency)
Measured: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Secondary outcomes (14)
Change from baseline in sleep hygiene practices at 2 months
Sleep Hygiene Index (0-48, higher is worse sleep hygiene)
Measured: Baseline and 2 months (post-enhanced cab)
Change from baseline in sleep hygiene practices at 3-4 months
Sleep Hygiene Index (0-48, higher is worse sleep hygiene)
Measured: 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
International Physical Activity Scale-Short Form moderate intensity physical activity question (0-7 days, more days is better moderate physical activity levels)
Measured: Baseline and 2 months (post-enhanced cab)
Change from baseline in self-reported moderate intensity physical activity at 3-4 months
International Physical Activity Scale-Short Form moderate intensity physical activity question (0-7 days, more days is better moderate physical activity levels)
Measured: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in self-reported vigorous intensity physical activity at 2 months
International Physical Activity Scale-Short Form vigorous physical activity question (0-7 days, more days is better vigorous intensity physical activity levels)
Measured: Baseline and 2 months (post-enhanced cab)
Change from baseline in self-reported vigorous intensity physical activity at 3-4 months
International Physical Activity Scale-Short Form vigorous physical activity question (0-7 days, more days is better vigorous intensity physical activity levels)
Measured: 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
Direct measurement via Actigraph GT3x+ BT (more minutes is better)
Measured: One week samples at 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
Direct measurement via Actigraph GT3x+ BT (more minutes is better)
Measured: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in actigraphy measures of 10-minute physical activity bouts at 2 months
Direct measurement via Actigraph GT3x+ BT (more bouts is better)
Measured: 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
Direct measurement via Actigraph GT3x+ BT (more bouts is better)
Measured: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in well-being (physical health) at 2 months
Physical Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better physical health)
Measured: Baseline and 2 months (post-enhanced cab)
Change from baseline in well-being (physical health) at 3-4 months
Physical Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better physical health)
Measured: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in well-being (mental health) at 2 months
Mental Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better mental health)
Measured: Baseline and 2 months (post-enhanced cab)
Change from baseline in well-being (mental health) at 3-4 months
Mental Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better mental health)
Measured: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 May 2017
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC), Washington State, Department of Labor and Industries, University of Washington
- Responsible party
- Principal investigator, Ryan Olson, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108599
- Sponsor's protocol ID
- 15440
- Acronym
- Tech4Rest
- Status last verified
- Jul 2024
- First submitted
- 30 Mar 2017
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
PubMed 20685078Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.
PubMed 22250775Ahsberg E. Dimensions of fatigue in different working populations. Scand J Psychol. 2000 Sep;41(3):231-41. doi: 10.1111/1467-9450.00192.
PubMed 11041305Mastin DF, Bryson J, Corwyn R. Assessment of sleep hygiene using the Sleep Hygiene Index. J Behav Med. 2006 Jun;29(3):223-7. doi: 10.1007/s10865-006-9047-6. Epub 2006 Mar 24.
PubMed 16557353Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
PubMed 22018588Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
PubMed 19543809Buxton OM, Quintiliani LM, Yang MH, Ebbeling CB, Stoddard AM, Pereira LK, Sorensen G. Association of sleep adequacy with more healthful food choices and positive workplace experiences among motor freight workers. Am J Public Health. 2009 Nov;99 Suppl 3(Suppl 3):S636-43. doi: 10.2105/AJPH.2008.158501.
PubMed 19890169Dennerlein JT, Hopcia K, Sembajwe G, Kenwood C, Stoddard AM, Tveito TH, Hashimoto DM, Sorensen G. Ergonomic practices within patient care units are associated with musculoskeletal pain and limitations. Am J Ind Med. 2012 Feb;55(2):107-16. doi: 10.1002/ajim.21036. Epub 2011 Nov 23.
PubMed 22113975Hedge A, Morimoto S, McCrobie D. Effects of keyboard tray geometry on upper body posture and comfort. Ergonomics. 1999 Oct;42(10):1333-49. doi: 10.1080/001401399184983.
PubMed 10582503Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.
PubMed 15676628Olson R, Johnson PW, Shea SA, Marino M, Springer R, Rice SPM, Rimby J, Donovan C. The Tech4Rest Randomized Controlled Trial: Applying the Hierarchy of Controls to Advance the Sleep, Health, and Well-being of Team Truck Drivers. J Occup Environ Med. 2023 Nov 1;65(11):937-948. doi: 10.1097/JOM.0000000000002941. Epub 2023 Aug 12.
PubMed 37590443
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engineering and Behavioral Controls for Truck Drivers' Sleep, Safety, and Health
- ClinicalTrials.gov ID
- NCT03108599
- Acronym / sponsor ID
- Tech4Rest / 15440
- Conditions
- Sleep, Sleep Disturbance, Sleep Disorder, Shift Work, Health Knowledge, Attitudes, Practice, Health Behavior, Fatigue
- Keywords
- Health Promotion, Injury Prevention, Safety, Wellbeing, Physical Activity, Sleep, Whole Body Vibration, Self-Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC), Washington State, Department of Labor and Industries, University of Washington
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Enhanced Cab, Behavioral: Fit4SleepAll 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. |
| Control | No intervention | –Usual practices with regards to cab conditions and access to workplace programs for preventing sleep and fatigue problems. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Non-treatment compliant for diagnosed Obstructive Sleep Apnea
- Driving teammate is unwilling, unable, or ineligible to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced CabThe enhanced cab 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 program. | Other | Intervention |
| Fit4SleepAlso: Behavioral Sleep ProgramThe behavioral sleep program includes a friendly dyad-based physical activity competition; self-monitoring and logging of physical activity, sleep hygiene behaviors, and sleep; and individual coaching. The behavioral sleep program includes an optional body weight management component. The intervention arm will receive the behavioral sleep program in combination with the enhanced cab intervention. | Behavioural | Intervention |
Primary outcome
Change from baseline in self-reported sleep duration in hours at 2 months
Time frame: 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 duration in hours at 3-4 months
Time frame: 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 2 months
Time frame: 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 self-reported sleep quality at 3-4 months
Time frame: 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 sleep disturbance at 2 months
Time frame: 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
Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
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
Time frame: 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
Time frame: 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 self-reported fatigue at 2 months
Time frame: 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
Time frame: 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 actigraphic measures of sleep duration in hours at 2 months
Time frame: 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 actigraphic measures of sleep duration in hours at 3-4 months
Time frame: 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 2 months
Time frame: One week samples at Baseline and 2 months (post-enhanced cab)
Direct measurement via Actigraph GT3x+ BT (higher percentage is better sleep efficiency)
Change from baseline in actigraphic measures of sleep efficiency percentage at 3-4 months
Time frame: 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)
14 secondary outcomes
Change from baseline in sleep hygiene practices at 2 months
Time frame: Baseline and 2 months (post-enhanced cab)
Change from baseline in sleep hygiene practices at 3-4 months
Time frame: 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
Time frame: Baseline and 2 months (post-enhanced cab)
Change from baseline in self-reported moderate intensity physical activity at 3-4 months
Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in self-reported vigorous intensity physical activity at 2 months
Time frame: Baseline and 2 months (post-enhanced cab)
Change from baseline in self-reported vigorous intensity physical activity at 3-4 months
Time frame: 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
Time frame: One week samples at 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
Time frame: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in actigraphy measures of 10-minute physical activity bouts at 2 months
Time frame: 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
Time frame: One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in well-being (physical health) at 2 months
Time frame: Baseline and 2 months (post-enhanced cab)
Change from baseline in well-being (physical health) at 3-4 months
Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in well-being (mental health) at 2 months
Time frame: Baseline and 2 months (post-enhanced cab)
Change from baseline in well-being (mental health) at 3-4 months
Time frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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- Background: PubMed 20685078Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
- Background: PubMed 22250775Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.
- Background: PubMed 11041305Ahsberg E. Dimensions of fatigue in different working populations. Scand J Psychol. 2000 Sep;41(3):231-41. doi: 10.1111/1467-9450.00192.
- Background: PubMed 16557353Mastin DF, Bryson J, Corwyn R. Assessment of sleep hygiene using the Sleep Hygiene Index. J Behav Med. 2006 Jun;29(3):223-7. doi: 10.1007/s10865-006-9047-6. Epub 2006 Mar 24.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 22018588Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
- Background: PubMed 19543809Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
- Background: PubMed 19890169Buxton OM, Quintiliani LM, Yang MH, Ebbeling CB, Stoddard AM, Pereira LK, Sorensen G. Association of sleep adequacy with more healthful food choices and positive workplace experiences among motor freight workers. Am J Public Health. 2009 Nov;99 Suppl 3(Suppl 3):S636-43. doi: 10.2105/AJPH.2008.158501.
- Background: PubMed 22113975Dennerlein JT, Hopcia K, Sembajwe G, Kenwood C, Stoddard AM, Tveito TH, Hashimoto DM, Sorensen G. Ergonomic practices within patient care units are associated with musculoskeletal pain and limitations. Am J Ind Med. 2012 Feb;55(2):107-16. doi: 10.1002/ajim.21036. Epub 2011 Nov 23.
- Background: PubMed 10582503Hedge A, Morimoto S, McCrobie D. Effects of keyboard tray geometry on upper body posture and comfort. Ergonomics. 1999 Oct;42(10):1333-49. doi: 10.1080/001401399184983.
- Background: PubMed 15676628Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Cab and Fit4Sleep in people with Sleep and Sleep Disturbance, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in self-reported sleep duration in hours at 2 months (time frame: Baseline and 2 months (post-enhanced cab)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108599, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.