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HealthyNCT02713503

Evaluating Electronic Devices in a Driving Simulator

An observational study of Healthy, run by Clemson University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 groups in NCT02713503
Study groupRoleWhat they receive
Healthy DriversDriving 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.

  1. Driving performance as assessed by lane tracking (5 discrete categories that correspond with lane positioning)

    Measured: 1 day

  2. Driving performance as assessed by speed maintenance (mean, range and variation of driver speed)

    Measured: 1 day

Secondary outcomes (2)
  1. Functional Object Detection peripheral task performance as assessed by detect and respond to stimuli in the drivers periphery

    Measured: 1 day

  2. 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.

  1. First posted18 Mar 2016 (estimated)
  2. Study startSep 2013
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

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)
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

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.

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