HealthyNCT02713503
Evaluating Electronic Devices in a Driving Simulator
An observational study of Healthy, run by Clemson University.
Trial summary
The purpose of this study is to evaluate a variety of technologies in a driving simulator. Specifically, this research will provide a direct comparison of driver performance measures under various modes of mobile device interaction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Driving Observation and VisionCoach
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Feb 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy drivers
Who may be able to join
- Licensed drivers who are over the age of 18 who meet the SC vision screening of 20/40
Who cannot join
- -
About this study
Official title: HFCV Mobile Device Vehicle Integration Assessment
The purpose of this study is to evaluate a variety of technologies in a driving simulator. Specifically, this research will provide a direct comparison of driver performance measures under various modes of mobile device interaction.
Read the detailed description
The purpose of this study is to evaluate a variety of technologies in a driving simulator. Specifically, this research will provide a direct comparison of driver performance measures under various modes of mobile device interaction. The study will be conducted at CU-ICAR using the DriveSafety CDS-250 driving simulator. The experiment will be a key step in understanding what driver performance challenges and errors may occur under various interaction modes in the driving context. Results will investigate differences in driving performance in the presence and absence of full device pairing with vehicle electronics and what criteria might be considered for proposed pairing requirements. The driving simulator tasks will focus on visual scanning ability while engaging in secondary tasks using mobile devices such as (but not limited to) handheld phones with and without Bluetooth, mounted touchscreen displays, various voice-based interfaces, and the novel display system. Tasks will include activities such as making voice calls, text messaging, searching for points of interest on maps, and traditional in-vehicle activities such as changing the temperature, fan speed, radio station, etc. The number of tasks and interaction modes will vary between participants with up to 6 modes included per participant (e.g. handheld, mounted ipad, voice control).
The technologies will be integrated with the DriveSafety CDS-250 driving simulator. Participants will complete the Functional Object Detection (FOD) visual scanning task that requires a driver to maintain lane position, respond to brake events in the central field of view, and respond to target events that appear in the periphery. In addition, participants will be asked to concurrently complete the mobile-device tasks using the interaction modes described previously and occasionally respond to notifications simulating connected-vehicle interactions. Primary outcomes will include driving performance (lane tracking and speed maintenance), FOD peripheral task performance (% identified, response time), FOD braking task performance (% identified, response time, false positive responses), and subjective measures including workload, interface preferences, and open ended items describing their reactions to each interface.
Participants will complete training to get comfortable driving the simulator while driving on a straight road and then repeat the task using the cruise control prior to driving the experimental conditions. Participants will be recruited by word of mouth as well as through the use of flyers, newspaper advertisements, and talks in the community. All data will be collected in the driving simulator lab at CU-ICAR. We plan to share the findings of this research with designers, practitioners and researchers at conferences and through academic publications.
Participants will complete a vision screening using a standard eye chart and will complete a visual scanning task using an interactive light board where the participants will stand (or sit) in front of a board with moving lights and asked to identify the locations, colors, letters and numbers of the lights by pressing their location on the board.
DriveSafety™ CDS-250 Driving Simulator The CDS-250 driving simulator is designed as a rehabilitation tool which occupies a smaller footprint than traditional driving simulators. The simulator has a partial cab consisting of an adjustable driver's seat, center console, instrument cluster, and standard vehicle controls (steering wheel, accelerator, brake). Two input buttons are located on the steering wheel in the "3:00" and "9:00" positions. The display consists of three 19" (diagonal) LCD screens each with a resolution of 1440 X 900 pixels. The left and right screens are each rotated 30 degrees off-plane from the center screen toward the driver. The total horizontal width of this display configuration is 49". In addition to using the driving simulator for driving related tasks, a variety of reaction time tasks have been developed to work on patients' coordinated muscle movements, information processing, and reaction times.
- Conditions
- Healthy
- Being tested
- Driving Observation, VisionCoach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving ObservationOther
Driving observation using the DriveSafety CDS-250 Driving Simulator.
VisionCoachOther
Visual field evaluation using VisionCoach
| Study group | Role | What they receive |
|---|---|---|
| Healthy Drivers | Driving Observation and VisionCoach Receives: Other: Driving Observation; Other: VisionCoach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving performance as assessed by lane tracking (5 discrete categories that correspond with lane positioning)
Measured: 1 day
Driving performance as assessed by speed maintenance (mean, range and variation of driver speed)
Measured: 1 day
Secondary outcomes (2)
Functional Object Detection peripheral task performance as assessed by detect and respond to stimuli in the drivers periphery
Measured: 1 day
Functional Object Detection braking task performance as assessed by detect and respond to stimuli by button pressing or braking
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clemson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Highway Traffic Safety Administration (NHTSA), Westat
- Responsible party
- Sponsor
- Investigators
- Johnell Brooks, PhD, Principal investigator, Clemson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713503
- Sponsor's protocol ID
- 2013-167
- Status last verified
- Mar 2016
- First submitted
- 12 Feb 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brooks J, Seeanner J, Hennessy S, Manganelli J, Crisler M, Rosopa P, Jenkins C, Anderson M, Drouin N, Belle L, Truesdail C, Tanner S. Interactive Tools for Measuring Visual Scanning Performance and Reaction Time. Am J Occup Ther. 2017 Mar/Apr;71(2):7102350010p1-20102350020p6. doi: 10.5014/ajot.2017.020461.
PubMed 28218598
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HFCV Mobile Device Vehicle Integration Assessment
- ClinicalTrials.gov ID
- NCT02713503
- Acronym / sponsor ID
- 2013-167
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Clemson UniversityUniversity, hospital or other
- Collaborators
- National Highway Traffic Safety Administration (NHTSA), Westat
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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 purpose of this study is to evaluate a variety of technologies in a driving simulator. Specifically, this research will provide a direct comparison of driver performance measures under various modes of mobile device interaction.
Detailed description
The purpose of this study is to evaluate a variety of technologies in a driving simulator. Specifically, this research will provide a direct comparison of driver performance measures under various modes of mobile device interaction. The study will be conducted at CU-ICAR using the DriveSafety CDS-250 driving simulator. The experiment will be a key step in understanding what driver performance challenges and errors may occur under various interaction modes in the driving context. Results will investigate differences in driving performance in the presence and absence of full device pairing with vehicle electronics and what criteria might be considered for proposed pairing requirements. The driving simulator tasks will focus on visual scanning ability while engaging in secondary tasks using mobile devices such as (but not limited to) handheld phones with and without Bluetooth, mounted touchscreen displays, various voice-based interfaces, and the novel display system. Tasks will include activities such as making voice calls, text messaging, searching for points of interest on maps, and traditional in-vehicle activities such as changing the temperature, fan speed, radio station, etc. The number of tasks and interaction modes will vary between participants with up to 6 modes included per participant (e.g. handheld, mounted ipad, voice control).
The technologies will be integrated with the DriveSafety CDS-250 driving simulator. Participants will complete the Functional Object Detection (FOD) visual scanning task that requires a driver to maintain lane position, respond to brake events in the central field of view, and respond to target events that appear in the periphery. In addition, participants will be asked to concurrently complete the mobile-device tasks using the interaction modes described previously and occasionally respond to notifications simulating connected-vehicle interactions. Primary outcomes will include driving performance (lane tracking and speed maintenance), FOD peripheral task performance (% identified, response time), FOD braking task performance (% identified, response time, false positive responses), and subjective measures including workload, interface preferences, and open ended items describing their reactions to each interface.
Participants will complete training to get comfortable driving the simulator while driving on a straight road and then repeat the task using the cruise control prior to driving the experimental conditions. Participants will be recruited by word of mouth as well as through the use of flyers, newspaper advertisements, and talks in the community. All data will be collected in the driving simulator lab at CU-ICAR. We plan to share the findings of this research with designers, practitioners and researchers at conferences and through academic publications.
Participants will complete a vision screening using a standard eye chart and will complete a visual scanning task using an interactive light board where the participants will stand (or sit) in front of a board with moving lights and asked to identify the locations, colors, letters and numbers of the lights by pressing their location on the board.
DriveSafety™ CDS-250 Driving Simulator The CDS-250 driving simulator is designed as a rehabilitation tool which occupies a smaller footprint than traditional driving simulators. The simulator has a partial cab consisting of an adjustable driver's seat, center console, instrument cluster, and standard vehicle controls (steering wheel, accelerator, brake). Two input buttons are located on the steering wheel in the "3:00" and "9:00" positions. The display consists of three 19" (diagonal) LCD screens each with a resolution of 1440 X 900 pixels. The left and right screens are each rotated 30 degrees off-plane from the center screen toward the driver. The total horizontal width of this display configuration is 49". In addition to using the driving simulator for driving related tasks, a variety of reaction time tasks have been developed to work on patients' coordinated muscle movements, information processing, and reaction times.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Drivers | – | Other: Driving Observation, Other: VisionCoachDriving Observation and VisionCoach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy drivers
Key inclusion criteria (1 listed)
- Licensed drivers who are over the age of 18 who meet the SC vision screening of 20/40
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Driving ObservationDriving observation using the DriveSafety CDS-250 Driving Simulator. | Other | Healthy Drivers |
| VisionCoachVisual field evaluation using VisionCoach | Other | Healthy Drivers |
Primary outcome
Driving performance as assessed by lane tracking (5 discrete categories that correspond with lane positioning)
Time frame: 1 day
Driving performance as assessed by speed maintenance (mean, range and variation of driver speed)
Time frame: 1 day
2 secondary outcomes
Functional Object Detection peripheral task performance as assessed by detect and respond to stimuli in the drivers periphery
Time frame: 1 day
Functional Object Detection braking task performance as assessed by detect and respond to stimuli by button pressing or braking
Time frame: 1 day
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 18 Mar 2016.
- Derived from this study: PubMed 28218598Brooks J, Seeanner J, Hennessy S, Manganelli J, Crisler M, Rosopa P, Jenkins C, Anderson M, Drouin N, Belle L, Truesdail C, Tanner S. Interactive Tools for Measuring Visual Scanning Performance and Reaction Time. Am J Occup Ther. 2017 Mar/Apr;71(2):7102350010p1-20102350020p6. doi: 10.5014/ajot.2017.020461.
- Individual participant dataSharing planned: No
Related trials for Healthy
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
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.
Johnell Brooks, PhD principal investigator
Clemson University
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Clemson University.
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 1 inclusion and 1 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 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Driving performance as assessed by lane tracking (5 discrete categories that correspond with lane positioning) (time frame: 1 day). The study lists 2 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 NCT02713503, which also lists 1 linked publication.
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 18 Mar 2016.