NCT03108599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

4.3 years

First QC Date

March 30, 2017

Last Update Submit

July 23, 2024

Conditions

Keywords

Health PromotionInjury PreventionSafetyWellbeingPhysical ActivitySleepWhole Body VibrationSelf-Monitoring

Outcome Measures

Primary Outcomes (14)

  • 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)

    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)

    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)

    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)

    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 \[greater sleep disturbance\])

    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 \[greater sleep disturbance\])

    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 \[greater sleep-related impairment\])

    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 \[greater sleep-related impairment\])

    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 \[more fatigue\])

    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 \[more fatigue\])

    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)

    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)

    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)

    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)

    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

    Baseline and 2 months (post-enhanced cab)

  • 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 self-reported vigorous intensity physical activity at 2 months

    Baseline and 2 months (post-enhanced cab)

  • +9 more secondary outcomes

Other Outcomes (32)

  • Change from baseline in body weight at 2 months

    Baseline and 2 months (post-enhanced cab)

  • Change from baseline in body weight at 3-4 months

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

  • Change from baseline in body mass index at 2 months

    Baseline and 2 months (post-enhanced cab)

  • +29 more other outcomes

Study Arms (2)

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.

Other: Enhanced CabBehavioral: Fit4Sleep

Control

NO INTERVENTION

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

Interventions

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.

Intervention
Fit4SleepBEHAVIORAL

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.

Also known as: Behavioral Sleep Program
Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (13)

  • 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.

    PMID: 2748771BACKGROUND
  • Cella 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.

    PMID: 20685078BACKGROUND
  • Yu 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.

    PMID: 22250775BACKGROUND
  • Ahsberg E. Dimensions of fatigue in different working populations. Scand J Psychol. 2000 Sep;41(3):231-41. doi: 10.1111/1467-9450.00192.

    PMID: 11041305BACKGROUND
  • Mastin 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.

    PMID: 16557353BACKGROUND
  • Craig 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.

    PMID: 12900694BACKGROUND
  • Lee 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.

    PMID: 22018588BACKGROUND
  • Hays 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.

    PMID: 19543809BACKGROUND
  • Buxton 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.

    PMID: 19890169BACKGROUND
  • Dennerlein 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.

    PMID: 22113975BACKGROUND
  • Hedge 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.

    PMID: 10582503BACKGROUND
  • Kuorinka 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.

    PMID: 15676628BACKGROUND
  • Olson 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.

MeSH Terms

Conditions

ParasomniasSleep Disorders, Circadian RhythmBehaviorHealth BehaviorFatigueMotor Activity

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersChronobiology DisordersDyssomniasOccupational DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 11, 2017

Study Start

May 1, 2017

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

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.

Locations