Automobile DrivingNCT06279520
Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study.
A study testing VR Driving Simulator, Computerized Neurocognitive Function Test and Driver Test Station in people with Automobile Driving, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults. This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Automobile Driving
- What is being tested?
- VR Driving Simulator, Computerized Neurocognitive Function Test and Driver Test Station
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Feb 2024to 31 Dec 2024
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals over the age of 19 who are currently driving.
- Individuals capable of understanding and following the researcher's instructions.
- Individuals who can understand the purpose of the research and have consented to participate
Who cannot join
- Those who have not signed the consent form.
- Individuals with a history of severe dizziness or epilepsy.
- Patients with restrictions on sitting in a wheelchair or chair for more than 30 minutes.
- Patients with severe shoulder pain.
- Patients whose range of motion in major joints is restricted by more than 50%.
- Pregnant women.
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- Patients with pressure sores.
- Patients with limitations on simulator use due to heterotopic ossification.
- Patients with acute fractures.
- Other patients for whom participation in the study is expected difficult.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Ja-Ho Leigh, M.D. Msc., mazican@gmail.com
About this study
The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults.
This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result
Read the detailed description
VR driving simulator is to evaluate the driving abilities of high-risk drivers, including the elderly and those with medical conditions, potentially prone to incapacitate driving.
It aims to evaluate whether drivers who were anticipated to have impaired driving ability can handle highly risky situations for traffic accidents. The results of this study can be used to make the drivers know their status and encourage them to take safety training. Until now, the evaluation of driving abilities could only be conducted at licensing centers. However, the use of VR technology can eliminate spatial limitations, offering a promising tool for the objective assessment of driving skills.
- Conditions
- Automobile Driving
- Being tested
- VR Driving Simulator, Computerized Neurocognitive Function Test, Driver Test Station, On-road field driving Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Driving SimulatorDevice
Evaluation of usual road driving abilities and assessment of response capabilities in accident-prone situations through a VR driving simulator
Computerized Neurocognitive Function TestOther
Evaluation of cognitive levels including attention and memory (the Trail Making Test, Digit Span Test, Auditory (or Visual) Continuous Performance Test , and Card Sorting)
Driver Test StationOther
Conducting qualified tests of a person's basic physical driving ability including steering, acceleration and braking, using Driver Test Station(Autoadapt AB, Stenkullen, Sweden)
On-road field driving TestOther
Researchers and driver's license supervisors ride in the driver's license test vehicle to evaluate the subject's actual driving ability. the validity of the VR simulator by comparing the results of the VR simulator with the actual vehicle driving ability.
| Study group | Role | What they receive |
|---|---|---|
| Adult drivers | Other | Individuals over the age of 19 who are currently driving Receives: Device: VR Driving Simulator; Other: Computerized Neurocognitive Function Test; Other: Driver Test Station; Other: On-road field driving Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of VR driving simulator
A questionnaire evaluating symptoms of simulator sickness such as dizziness or nausea and comprehension of contents
Measured: 2 hours
Driving performance in simulator, measured by driving errors
Driving performance in simulator will be measured by driving errors during VR simluation of driving. These errors will be evaluated based on the criteria used for driving license tests, including violations of traffic laws.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start19 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Automobile DrivingStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ja-Ho Leigh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279520
- Sponsor's protocol ID
- 2023-08-003
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study.
- ClinicalTrials.gov ID
- NCT06279520
- Acronym / sponsor ID
- 2023-08-003
- Conditions
- Automobile Driving
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Feb 2024 (actual)
- 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 primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults.
This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result
Detailed description
VR driving simulator is to evaluate the driving abilities of high-risk drivers, including the elderly and those with medical conditions, potentially prone to incapacitate driving.
It aims to evaluate whether drivers who were anticipated to have impaired driving ability can handle highly risky situations for traffic accidents. The results of this study can be used to make the drivers know their status and encourage them to take safety training. Until now, the evaluation of driving abilities could only be conducted at licensing centers. However, the use of VR technology can eliminate spatial limitations, offering a promising tool for the objective assessment of driving skills.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult drivers | Other | Device: VR Driving Simulator, Other: Computerized Neurocognitive Function Test, Other: Driver Test Station, Other: On-road field driving TestIndividuals over the age of 19 who are currently driving |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals over the age of 19 who are currently driving.
- Individuals capable of understanding and following the researcher's instructions.
- Individuals who can understand the purpose of the research and have consented to participate
Key exclusion criteria (10 listed)
- Those who have not signed the consent form.
- Individuals with a history of severe dizziness or epilepsy.
- Patients with restrictions on sitting in a wheelchair or chair for more than 30 minutes.
- Patients with severe shoulder pain.
- Patients whose range of motion in major joints is restricted by more than 50%.
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 |
|---|---|---|
| VR Driving SimulatorEvaluation of usual road driving abilities and assessment of response capabilities in accident-prone situations through a VR driving simulator | Device | Adult drivers |
| Computerized Neurocognitive Function TestEvaluation of cognitive levels including attention and memory (the Trail Making Test, Digit Span Test, Auditory (or Visual) Continuous Performance Test , and Card Sorting) | Other | Adult drivers |
| Driver Test StationConducting qualified tests of a person's basic physical driving ability including steering, acceleration and braking, using Driver Test Station(Autoadapt AB, Stenkullen, Sweden) | Other | Adult drivers |
| On-road field driving TestResearchers and driver's license supervisors ride in the driver's license test vehicle to evaluate the subject's actual driving ability. the validity of the VR simulator by comparing the results of the VR simulator with the actual vehicle driving ability. | Other | Adult drivers |
Primary outcome
Feasibility of VR driving simulator
Time frame: 2 hours
A questionnaire evaluating symptoms of simulator sickness such as dizziness or nausea and comprehension of contents
Driving performance in simulator, measured by driving errors
Time frame: 15 minutes
Driving performance in simulator will be measured by driving errors during VR simluation of driving. These errors will be evaluated based on the criteria used for driving license tests, including violations of traffic laws.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Driving Simulator, Computerized Neurocognitive Function Test and Driver Test Station in people with Automobile Driving, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ja-Ho Leigh (+82-31-580-5650, magican1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of VR driving simulator (time frame: 2 hours). 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?
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 28 Feb 2024.