Eye Scanning for Safety Driving

NCT06396273 | Active Not Recruiting

• 1 other identifier: LoughboroughUn
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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\'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\'s disease or dementia.

Conditions

Dementia; Mild Cognitive Impairment; Older Adults

Outcome Measures

Primary Outcomes (1)

• Visual screening

  saccade eye movement using eye tracker

  only baseline

Secondary Outcomes (6)

• Visual Sensitivity test

  only baseline

• driving performance

  only baseline

• Driving experience survey

  only baseline

• Corsi Block Span Test

  only baseline

• Hopkins Verbal Learning Test

  only baseline

Study Arms (2)

participants with cognitive impairment aged 65

older adults without cognitive impairment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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, \<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:

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loughborough University: lead
• Monash University: collaborator

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 2, 2024
• Study Start: November 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: December 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

GB (1)