Tech4Rest Trial With Team Truck Drivers (Tech4Rest)

July 23, 2024 updated by: Ryan Olson, Oregon Health and Science University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.
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.
Other Names:
  • Behavioral Sleep Program
No Intervention: Control
Usual practices with regards to cab conditions and access to workplace programs for preventing sleep and fatigue problems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and 2 months (post-enhanced cab)
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)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
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)
Baseline and 2 months (post-enhanced cab)
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)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
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])
Baseline and 2 months (post-enhanced cab)
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])
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
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])
Baseline and 2 months (post-enhanced cab)
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])
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
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])
Baseline and 2 months (post-enhanced cab)
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])
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
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)
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
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)
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
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)
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
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)
One week samples at Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in sleep hygiene practices at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Sleep Hygiene Index (0-48, higher is worse sleep hygiene)
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)
Sleep Hygiene Index (0-48, higher is worse sleep hygiene)
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)
International Physical Activity Scale-Short Form moderate intensity physical activity question (0-7 days, more days is better moderate physical activity levels)
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)
International Physical Activity Scale-Short Form moderate intensity physical activity question (0-7 days, more days is better moderate physical activity levels)
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)
International Physical Activity Scale-Short Form vigorous physical activity question (0-7 days, more days is better vigorous intensity physical activity levels)
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)
International Physical Activity Scale-Short Form vigorous physical activity question (0-7 days, more days is better vigorous intensity physical activity levels)
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)
Direct measurement via Actigraph GT3x+ BT (more minutes is better)
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)
Direct measurement via Actigraph GT3x+ BT (more minutes is better)
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)
Direct measurement via Actigraph GT3x+ BT (more bouts is better)
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)
Direct measurement via Actigraph GT3x+ BT (more bouts is better)
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)
Physical Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better physical health)
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)
Physical Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better physical health)
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)
Mental Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better mental health)
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)
Mental Health Subscale of the Patient-Reported Outcomes Measurement Information System Global Health Scale (4-20, higher is better mental health)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in body weight at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer (higher weight is worse)
Baseline and 2 months (post-enhanced cab)
Change from baseline in body weight at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer (higher weight is worse)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in body mass index at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Direct measurement via stadiometer and Tanita TBF-310GS Bioelectric Impedance Analyzer (higher body mass index is worse)
Baseline and 2 months (post-enhanced cab)
Change from baseline in body mass index at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Direct measurement via stadiometer and Tanita TBF-310GS Bioelectric Impedance Analyzer (higher body mass index is worse)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in percent body fat at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer (higher percent body fat is worse)
Baseline and 2 months (post-enhanced cab)
Change from baseline in percent body fat at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer (higher percent body fat is worse)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in systolic blood pressure at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Direct measurement via Omron HEM-907 automatic blood pressure monitor (higher systolic blood pressure is worse)
Baseline and 2 months (post-enhanced cab)
Change from baseline in systolic blood pressure at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Direct measurement via Omron HEM-907 automatic blood pressure monitor (higher systolic blood pressure is worse)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in diastolic blood pressure at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Direct measurement via Omron HEM-907 automatic blood pressure monitor (higher diastolic blood pressure is worse)
Baseline and 2 months (post-enhanced cab)
Change from baseline in diastolic blood pressure at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Direct measurement via Omron HEM-907 automatic blood pressure monitor (higher diastolic blood pressure is worse)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in fruit and vegetable servings per day at 2 months
Time Frame: Baseline and 2 months (post-enhanced cabs)
Single-item on number of fruit and vegetable servings developed by investigators (0-5+, more servings is better)
Baseline and 2 months (post-enhanced cabs)
Change from baseline in fruit and vegetable servings per day at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Single-item on number of fruit and vegetable servings developed by investigators (0-5+, more servings is better)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in frequency of meals brought from home at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)
Baseline and 2 months (post-enhanced cab)
Change from baseline in frequency of meals brought from home at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in frequency of consumption of sugary snacks at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)
Baseline and 2 months (post-enhanced cab)
Change from baseline in frequency of consumption of sugary snacks at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in frequency of sugary drink consumption at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)
Baseline and 2 months (post-enhanced cab)
Change from baseline in frequency of sugary drink consumption at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program
single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program
Change from baseline in frequency of fast food consumption at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)
Baseline and 2 months (post-enhanced cab)
Change from baseline in frequency of fast food consumption at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
single item from prior research by other investigators (0 [Never] to 9 [5 or more times per day], higher is better)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in pain interference with home and work activities at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Adapted Nordic-style questionnaire for musculoskeletal symptoms (5-25, higher is worse [greater pain interference])
Baseline and 2 months (post-enhanced cab)
Change from baseline in pain interference with home and work activities at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Adapted Nordic-style questionnaire for musculoskeletal symptoms (5-25, higher is worse [greater pain interference])
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in pain intensity at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Adapted Nordic-style questionnaire for musculoskeletal symptoms (0-50, higher is worse pain)
Baseline and 2 months (post-enhanced cab)
Change from baseline in pain intensity at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Adapted Nordic-style questionnaire for musculoskeletal symptoms (0-50, higher is worse pain)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in driving vehicle collisions without damage at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Self-reported vehicle collisions without damage using item created by investigators (0-5+, more is worse)
Baseline and 2 months (post-enhanced cab)
Change from baseline in driving vehicle collisions without damage at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Self-reported vehicle collisions without damage using item created by investigators (0-5+, more is worse)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in driving vehicle collisions with damage at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Self-reported vehicle collisions with damage using two items created by investigators (0-5+, more is worse)
Baseline and 2 months (post-enhanced cab)
Change from baseline in driving vehicle collisions with damage at 2 and 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Self-reported vehicle collisions with damage using two items created by investigators (0-5+, more is worse)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in minor injuries at work at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Self-reported worker injuries without lost work time using item created by investigators (0-5+, more is worse)
Baseline and 2 months (post-enhanced cab)
Change from baseline in minor injuries at work at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Self-reported worker injuries without lost work time using item created by investigators (0-5+, more is worse)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Change from baseline in major injuries at work at 2 months
Time Frame: Baseline and 2 months (post-enhanced cab)
Self-reported worker injuries resulting in lost work time using item created by investigators (0-5+, more is worse)
Baseline and 2 months (post-enhanced cab)
Change from baseline in major injuries at work at 3-4 months
Time Frame: Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)
Self-reported worker injuries resulting in lost work time using item created by investigators (0-5+, more is worse)
Baseline and 3-4 months (post-enhanced cab + behavioral sleep program)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 15440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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