Clinical trial NCT06396273: Eye Scanning for Safety Driving
Official title: Vision-Based Assessment of Driving Ability in Individuals With Dementia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dementia
Mild Cognitive Impairment
Older Adults
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: Monash University
First posted: 2024-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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, \&lt;24 cut-off score) and Hopkins Verbal Learning Test (HVLT, \&lt;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:

Brief 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. The study aims to address the research gap on the specific eye movement patterns and visual behaviors of individuals with Alzheimer\&amp;#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\&amp;#39;s disease or dementia.


Eligibility criteria: Inclusion Criteria:

* Participants with cognitive impairment aged 65 and/or older and older adults without cognitive impairment will be recruited for this study.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual screening
timeFrame: only baseline
Secondary outcomes:
measure: Visual Sensitivity test
timeFrame: only baseline
measure: driving performance
timeFrame: only baseline
measure: Driving experience survey
timeFrame: only baseline
measure: Corsi Block Span Test
timeFrame: only baseline
measure: Hopkins Verbal Learning Test
timeFrame: only baseline
measure: Mini Mental State Examination
timeFrame: only baseline
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
References: