Eye Scanning for Safety Driving

Dementia Clinical Trial

Official title:

Vision-Based Assessment of Driving Ability in Individuals With Dementia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06396273
• Other study ID #: LoughboroughUn
• Status: Active, not recruiting
• Start date: November 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Older Adults

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
Loughborough University	Monash University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual screening	saccade eye movement using eye tracker	only baseline
Secondary	Visual Sensitivity test	to measure visual processing speed	only baseline
Secondary	driving performance	Hazard perception test (DVLA)	only baseline
Secondary	Driving experience survey	driving performance	only baseline
Secondary	Corsi Block Span Test	to measure visuospatial working memory	only baseline
Secondary	Hopkins Verbal Learning Test	verbal memory	only baseline
Secondary	Mini Mental State Examination	Global cognition	only baseline