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.

Sleep

Sleep Disturbance

Sleep Disorder, Shift Work

Health Knowledge, Attitudes, Practice

Health Behavior

Fatigue

Vibration; Exposure

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.

Enhanced Cab

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.

Fit4Sleep

Oregon Health and Science University

Tech4Rest Trial With Team Truck Drivers

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

Direct measurement via Actigraph GT3x+ BT

Pittsburgh Sleep Quality Index (Buysse et al., 1989)

PROMIS Sleep-Related Impairment (Cella et al., 2010; Yu et al., 2012)

Psychomotor Vigilance Task (Dinges & Powell, 1985; Basner & Dinges, 2011)

Swedish Occupational Fatigue Inventory (Ahsberg, 2000)

Objective truck engine records of fuel efficiency and hard brakes (decelerations >7mph per second) per 10,000 miles driven will be collected from companies

Healthy physical activity scale (Elliot et al., 2007)

Sedentary Behavior Questionnaire for adults (Rosenberg et al., 2010)

Sleep Hygiene Index (Mastin et al., 2006)

PROMIS Global Health (Cella et al., 2007, Hays et al., 2009)

Adapted Nordic questionnaire for musculoskeletal symptoms (Kuorinka et al., 1987)

Roland Morris Disability Index (Roland et al., 1983)

Self-reported and/or company collected data on worker injuries and lost work days due to injury

Self-reported and/or company collected data

Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer

Direct measurement via Omron HEM-907 automatic blood pressure monitor

Single-item on number of fruit and vegetable servings developed for study

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.

Ryan Olson

Associate Professor

National Institute for Occupational Safety and Health (NIOSH/CDC)

Washington State, Department of Labor and Industries

University of Washington

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.

Subjects will receive 3 mg melatonin once a day.

Subjects will receive 5 mg melatonin once a day.

Relapsing Remitting Multiple Sclerosis

3 mg Melatonin

5 mg Melatonin

Providence MS Center

Melatonin in Patients With Multiple Sclerosis (MS).

Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS)

Changes in 24-hour urinary 6-sulfatoxymelatonin and serum morning Melatonin over time

Changes in the MFIS: Modified Fatigue Impact Scale (MFIS) is a PRO, consisting of 21 statements that describe the effect of fatigue. Subject will choose an answer (0= never to 4=always) that best describes how fatigue has affected them in the past 4 weeks. Item scores are summed to a total score. The total MFIS score ranges from 0 to 84. Higher scores indicate higher level of fatigue.

Changes is morning blood levels of melatonin

Changes in the MSIS-29: Multiple Sclerosis Impact Scale (MSIS) is a patient reported outcome (PRO) measure, consisting of two subscales- physical impact of MS (20 items) and psychological impact (9 items). It asks subject to rate the impact MS has their daily life in the past 2 weeks (1=low impact to 4=large impact). Scores from individual items are summed to a total score. Physical impact score ranges from 20-80 and psychological impact scores ranges from 9-36. Higher scores indicate greater impact of MS on QoL.

Changes in PSQI: Pittsburgh Sleep Quality Index (PSQI) asks 10 sets of questions about sleep quality and pattern in the past month. The scale derive 7 component scores based on a 0 to 3 scale (0= no difficulty, 3=severe difficulty) which are summed to a global score (range 0 to 21). Higher scores indicates worse sleep quality.

Changes in PDDS-PS: Patient Determined Disease Steps Performance Scales (PDDS-PS) is a PRO for MS disease status. Subject self-classify their level of disability on a 0 to 8 scale (0=Normal to 8=Bedridden) with 8 being the most disabled.

Providence Health & Services

Subjects will be randomly assigned to receive melatonin at 3 milligrams (mg) once a day or 5mg once a day. The study drug will be taken at 21:00 each day ± 2 hours.

The study is blinded to patients and providers.

Parkinson's Disease

pramipexole

Oregon Health & Science University

Effects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's Disease

Effects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's Disease: a Double-Blind Placebo Controlled Crossover Study

Matthew Brodsky M.D.

Boehringer Ingelheim

In this group subjects will receive 1 vitamin D3 capsule of 50,000 units, each week, for 12 weeks.

In this group the subjects will receive 1 placebo capsule each week for 12 weeks.

Fibromyalgia

D Vitamin Deficiency

Women diagnosed with Fibromyalgia from the outpatient clinic of the "Dr. José Eleuterio González" University Hospital of the Autonomous University of Nuevo Leon.

Subjects will receive a capsule of 50,000 units of vitamin D3 echa week for 12 weeks, basal levels of vitamin D will be taken and again at week 12.

D3 Vitamin

Placebo

Universidad Autónoma de Nuevo León

Valuation of Efficacy and Safety of Vitamin D3 Use in 80 Women Diagnosed With Fibromyalgia. Using FIQ Score and VAS.

Randomized, Double-blind, Placebo-controlled Trial to Measure the Efficacy and Safety of Vitamin D3 in Patients With Fibromyalgia.

Number of items in scale: The version from 19911 consisted of 10 items with 10 sub-items in the physical function scale (total items + sub-items = 19). The modified version from 1997 consists of 20 items with 11 physical function items (total items + sub-items = 30). The 2009 version consists of 21 items across the 3 domains of Function (n = 9), Overall Impact (n = 2), and Symptoms (n = 10).
Subscales: Subscales from the 1991 version1 include physical function (10 sub-items), feel good (1 item), missed work (1 item), do job (1 item), pain (1 item), fatigue (1 item), rested (1 item), stiffness (1 item), anxiety (1 item), and depression (1 item).

Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.

oregon/fatica

Tech4Rest Trial With Team Truck Drivers

Melatonin in Patients With Multiple Sclerosis (MS).

Effects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's Disease

Valuation of Efficacy and Safety of Vitamin D3 Use in 80 Women Diagnosed With Fibromyalgia. Using FIQ Score and VAS.

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