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Trial registered on ANZCTR


Registration number
ACTRN12624001322527p
Ethics application status
Submitted, not yet approved
Date submitted
17/07/2024
Date registered
31/10/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
31/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the use of eye tracking for identifying clinical biomarkers with physiological changes
Scientific title
Investigating the use of eye tracking for identifying clinical biomarkers with physiological changes in healthy participants
Secondary ID [1] 312253 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular motor (eye tracking) dysfunction 333969 0
Condition category
Condition code
Eye 330631 330631 0 0
Diseases / disorders of the eye
Neurological 330636 330636 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventional study involves assessing eye movements with a portable eye tracking device to investigate the effect of caffeine and alcohol on eye movement control.

The portable eye tracking device consists of an eye piece and internal screen and camera. One version of the device will be handheld, while the other version of the device is head mounted (similar to a virtual reality headset). The participant will be allocated one of the device versions for the eye tracking assessment. For the handheld device, the participant will be instructed to hold the device eye piece against their eyes, which will be the only part of the device that contacts their face. For the head mounted device, the researcher will place the head strap on their head. The participant will be instructed to hold the device eye piece against their eye, which will be the only part of the device that contacts their face, and follow a target (moving dot) on a screen that will play a series of eye tracking tasks. A video recording of the eye movements in each eye is captured and analysed.

Healthy participants will have baseline eye tracking prior to any alcohol or caffeine consumption, and repeat eye tracking every 30 minutes up to 3 hours after alcohol or caffeine consumption. The caffeine group will also have a late time point on the same day, 8 hours post-intake. The alcohol group will also undergo eye tracking the next morning (in the absence of caffeine), along with Blood Alcohol Concentration (BAC) measurements (i.e. to measure “hangover” effect, if any).

The following groups are:

Caffeine dosage and groups:
1. Coffee 63mg (1 shot espresso)
2. Coffee 125mg (2 shot espresso)
3. Coffee 190mg (3 shot espresso)
4. Red bull energy drink (80mg)
5. Control group: Decaffeinated coffee (2mg caffeine)

Alcohol groups:
1. 0.01-0.05% BAC as determined via breathalyser.
2. 0.06-0.10% BAC
3. 0.11-0.15% BAC
4. 0.16-0.20% BAC
5. Control group: Non-alcoholic beverage e.g. (0% alcohol content soda)
Intervention code [1] 328702 0
Diagnosis / Prognosis
Intervention code [2] 328703 0
Early detection / Screening
Intervention code [3] 329139 0
Treatment: Devices
Comparator / control treatment
The treatment has a control group: healthy volunteers who will consume a beverage without any presence of alcohol or caffeine content. These participants will also have baseline eye tracking prior to any alcohol or caffeine consumption, and repeat eye tracking at the following time points: every 30 minutes up to 3 hours after consumption of the placebo beverage. They will also have a late time point on the same day, 8 hours post-intake.
Control group
Placebo

Outcomes
Primary outcome [1] 338378 0
Eye tracking measures (in particular fixation, smooth pursuit and saccades) will be assessed. These measures are assessed as a composite primary outcome.
Timepoint [1] 338378 0
Caffeine group timepoints: Baseline prior to caffeine intake, and repeat eye tracking at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes after caffeine intake. Repeat eye tracking will also be performed at the timepoint 8 hours after caffeine intake to measure any effect of fatigue.
Alcohol group timepoints: Baseline prior to alcohol intake, and repeat eye tracking at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes after alcohol intake. Repeat eye tracking will also be performed the next morning to measure 'hangover effect' if any.
Secondary outcome [1] 435681 0
Blood pressure
Timepoint [1] 435681 0
Caffeine group: Baseline prior to caffeine intake, and repeat measurement at 30 minutes, 3 hours and 8 hours after caffeine intake.
Alcohol group: Baseline prior to alcohol intake, and repeat measurement at 30 minutes, 3 hours and the following morning after alcohol intake.
Secondary outcome [2] 435682 0
Blood alcohol content
Timepoint [2] 435682 0
Alcohol group only: Baseline prior to alcohol intake, and repeat measurement at 30 minutes, 3 hours and the following morning after alcohol intake.
Secondary outcome [3] 435683 0
Behavioural alertness
Timepoint [3] 435683 0
Alcohol group only: Baseline assessment prior to alcohol intake, and repeat assessment at 30 minutes and 3 hours after alcohol intake. Repeat assessment will also be performed the following morning after alcohol intake.
Secondary outcome [4] 440356 0
Heart rate
Timepoint [4] 440356 0
Caffeine group: Baseline prior to caffeine intake, and repeat measurement at 30 minutes, 3 hours and 8 hours after caffeine intake.
Alcohol group: Baseline prior to alcohol intake, and repeat measurement at 30 minutes, 3 hours and the following morning after alcohol intake.

Eligibility
Key inclusion criteria
Healthy participants, aged 18 and above from the community.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those with any active or past neurological pathology (e.g. trauma, vascular, epilepsy, schizophrenia), cardiovascular risk, liver disease, pregnancy, and diabetes will be excluded. We will also exclude those with refractive errors > +/- 5.00 Dioptres. Participants taking any medication that interferes with alcohol or caffeine consumption will be excluded, along with alcohol dependency, frequent alcohol intake (>4x/week), or substance misuse disorders.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26356 0
New Zealand
State/province [1] 26356 0

Funding & Sponsors
Funding source category [1] 316631 0
Charities/Societies/Foundations
Name [1] 316631 0
Vision Research Foundation
Country [1] 316631 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
VRF Vault Ltd
Address
Country
New Zealand
Secondary sponsor category [1] 318819 0
None
Name [1] 318819 0
Address [1] 318819 0
Country [1] 318819 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315413 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 315413 0
Ethics committee country [1] 315413 0
New Zealand
Date submitted for ethics approval [1] 315413 0
17/07/2024
Approval date [1] 315413 0
Ethics approval number [1] 315413 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134630 0
Prof Helen Danesh-Meyer
Address 134630 0
Vision Research Foundation. 123 Remuera Road, Auckland 1050
Country 134630 0
New Zealand
Phone 134630 0
+64 211324971
Fax 134630 0
Email 134630 0
helen@vrf.org.nz
Contact person for public queries
Name 134631 0
Helen Danesh-Meyer
Address 134631 0
Vision Research Foundation. 123 Remuera Road, Auckland 1050
Country 134631 0
New Zealand
Phone 134631 0
+64 211324971
Fax 134631 0
Email 134631 0
helen@vrf.org.nz
Contact person for scientific queries
Name 134632 0
Professor Helen Danesh-Meyer
Address 134632 0
Vision Research Foundation. 123 Remuera Road, Auckland 1050
Country 134632 0
New Zealand
Phone 134632 0
+64 211324971
Fax 134632 0
Email 134632 0
helen@vrf.org.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.