DementiaNCT06396273
Eye Scanning for Safety Driving
An observational study of Dementia and Mild Cognitive Impairment, run by Loughborough University at 1 site in United Kingdom.
Trial summary
This is an experimental study protocol to investigate the use of vision-based assessments like eye-tracking and visual processing tests to evaluate driving ability in older adults with and without dementia. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment, Older Adults
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2023to 1 Dec 2024
- How long will I take part?
- 1 Day
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: participants with cognitive impairment aged 65 and/or older and 20 older adults without cognitive impairment will be recruited for this study. Participants' cognitive status will be assessed using the Mini-Mental State Examination (MMSE, \<24 cut-off score) and Hopkins Verbal Learning Test (HVLT, \<19 cut-off score). Instrumental activities of daily living (IADL) (see below) is used to establish where the cognitive impairment in MCI or dementia. Exclusion criteria will be the following:
Who may be able to join
- Participants with cognitive impairment aged 65 and/or older and older adults without cognitive impairment will be recruited for this study.
Who cannot join
- Participants with other neurological disease (stroke, Parkinson's, or multiple sclerosis),
- Psychiatric conditions (depression, anxiety disorder, etc.) and a history of severe psychiatric disorders (schizoaffective/bipolar disorders, or schizophrenia),
- Severe vision/hearing impairments that cannot be corrected with aids,
- Unable to comprehend questionnaire material study procedures and give consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
Official title: Vision-Based Assessment of Driving Ability in Individuals With Dementia
This is an experimental study protocol to investigate the use of vision-based assessments like eye-tracking and visual processing tests to evaluate driving ability in older adults with and without dementia. The study aims to address the research gap on the specific eye movement patterns and visual behaviors of individuals with Alzheimer\&#39;s disease during high-risk driving scenarios.
The study will recruit 15 participants aged 65+ with cognitive impairment and 15 without cognitive impairment. Their cognitive status will be assessed using the Mini-Mental State Exam (MMSE) and Hopkins Verbal Learning Test (HVLT). Participants will undergo visual screening tests like visual sensitivity, eye movement scanning, and the Corsi block span test. Their driving performance will be evaluated through a hazard perception test and driving experience survey.
Read more
Statistical analyses like correlations, group comparisons, regression, and mediation analyses will be conducted to examine the relationships between cognitive status, visual screening scores, and driving performance scores. The goal is to determine if visual measures can predict driving ability and mediate the link between cognitive function and driving performance in those with dementia.
In summary, it is a protocol for an observational study using vision-based techniques to assess driving capacity in older adults, especially those with Alzheimer\&#39;s disease or dementia.
- Conditions
- Dementia, Mild Cognitive Impairment, Older Adults
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| participants with cognitive impairment aged 65 | Not described | |
| older adults without cognitive impairment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual screening
saccade eye movement using eye tracker
Measured: only baseline
Secondary outcomes (6)
Visual Sensitivity test
to measure visual processing speed
Measured: only baseline
driving performance
Hazard perception test (DVLA)
Measured: only baseline
Driving experience survey
driving performance
Measured: only baseline
Corsi Block Span Test
to measure visuospatial working memory
Measured: only baseline
Hopkins Verbal Learning Test
verbal memory
Measured: only baseline
Mini Mental State Examination
Global cognition
Measured: only baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Nov 2023
- Primary completion30 May 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Principal investigator, Ahmet Begde, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396273
- Sponsor's protocol ID
- LoughboroughUn
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision-Based Assessment of Driving Ability in Individuals With Dementia
- ClinicalTrials.gov ID
- NCT06396273
- Acronym / sponsor ID
- LoughboroughUn
- Conditions
- Dementia, Mild Cognitive Impairment, Older Adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 May 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.
This is an experimental study protocol to investigate the use of vision-based assessments like eye-tracking and visual processing tests to evaluate driving ability in older adults with and without dementia. The study aims to address the research gap on the specific eye movement patterns and visual behaviors of individuals with Alzheimer\&#39;s disease during high-risk driving scenarios.
The study will recruit 15 participants aged 65+ with cognitive impairment and 15 without cognitive impairment. Their cognitive status will be assessed using the Mini-Mental State Exam (MMSE) and Hopkins Verbal Learning Test (HVLT). Participants will undergo visual screening tests like visual sensitivity, eye movement scanning, and the Corsi block span test. Their driving performance will be evaluated through a hazard perception test and driving experience survey.
Statistical analyses like correlations, group comparisons, regression, and mediation analyses will be conducted to examine the relationships between cognitive status, visual screening scores, and driving performance scores. The goal is to determine if visual measures can predict driving ability and mediate the link between cognitive function and driving performance in those with dementia.
In summary, it is a protocol for an observational study using vision-based techniques to assess driving capacity in older adults, especially those with Alzheimer\&#39;s disease or dementia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| participants with cognitive impairment aged 65 | – | – |
| older adults without cognitive impairment | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- participants with cognitive impairment aged 65 and/or older and 20 older adults without cognitive impairment will be recruited for this study. Participants' cognitive status will be assessed using the Mini-Mental State Examination (MMSE, \<24 cut-off score) and Hopkins Verbal Learning Test (HVLT, \<19 cut-off score). Instrumental activities of daily living (IADL) (see below) is used to establish where the cognitive impairment in MCI or dementia. Exclusion criteria will be the following:
Key inclusion criteria (1 listed)
- Participants with cognitive impairment aged 65 and/or older and older adults without cognitive impairment will be recruited for this study.
Key exclusion criteria (4 listed)
- Participants with other neurological disease (stroke, Parkinson's, or multiple sclerosis),
- Psychiatric conditions (depression, anxiety disorder, etc.) and a history of severe psychiatric disorders (schizoaffective/bipolar disorders, or schizophrenia),
- Severe vision/hearing impairments that cannot be corrected with aids,
- Unable to comprehend questionnaire material study procedures and give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual screening
Time frame: only baseline
saccade eye movement using eye tracker
6 secondary outcomes
Visual Sensitivity test
Time frame: only baseline
driving performance
Time frame: only baseline
Driving experience survey
Time frame: only baseline
Corsi Block Span Test
Time frame: only baseline
Hopkins Verbal Learning Test
Time frame: only baseline
Mini Mental State Examination
Time frame: only baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Mild Cognitive Impairment, run by Loughborough University at 1 site in United Kingdom.
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 4 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 2 May 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 United Kingdom. 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?
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?
Visual screening (time frame: only baseline). 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 2 May 2024.