An Observational Study to Facilitate the Development of an Alcohol Impairment Detection Device in Healthy Adult Alcohol Users
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Alcohol-Associated Ocular Impairments
Study Overview
Brief Summary
This study evaluates the effectiveness of the Gaize virtual reality headset as a non-invasive tool for detecting alcohol-related impairment through ophthalmic and neurological indicators. A total of 80 participants, evenly divided into an experimental (alcohol-consuming) and control (non-alcohol consuming) group, underwent baseline and post-consumption ocular assessments using the device. These assessments included: Lack of Smooth Pursuit, Horizontal Gaze Nystagmus at Maximum Deviation, Horizontal Gaze Nystagmus with Onset Prior to 45-Degrees, Vertical Gaze Nystagmus, Lack of Convergence, and Pupillary Rebound Dilation. The Gaize headset measured gaze vector and pupil size at 90 hertz per eye.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults aged between 21 and 45, having given written informed consent to participate in the research trial and certifying that they do not intend to drive post discharge. We will consider extending the observation period based on individual participants' alcohol consumption.
- •Having used alcohol at least one time prior.
- •Having experienced impairment too severe to allow for safe operation of a vehicle or work from alcohol use.
- •Planning to drink alcohol during their time at the study location.
- •Without any history of severe reactions or allergy to alcohol.
- •Having access to legal alcohol.
- •Normal or corrected to normal vision using either glasses or contact lenses, or surgery.
Exclusion Criteria
- •Enrolled in, or participated in another clinical trial within 30 days before the study
- •Having a prosthetic eye, blindness, or vision not corrected to normal.
- •Severe reactions or allergy to Alcohol. Participants with a history of severe adverse reactions to alcohol (e.g., allergies, intolerances, or medical conditions worsened by alcohol) are excluded.
- •Certain Medical Conditions: Participants with medical conditions or medications that could significantly affect cognitive and motor functions are excluded. A detailed list of such conditions and medications will be provided to potential participants during the screening process.
- •Pregnancy: Pregnant individuals will be excluded from the study due to the potential risks associated with alcohol consumption during pregnancy.
- •History of Severe Motion Sickness: Participants with a history of severe motion sickness in virtual reality environments may be excluded, as they may not tolerate the virtual reality headset well.
- •Individuals who have driven a vehicle (car, truck, bicycle, etc.) to the study location will not be eligible for participation.
Arms & Interventions
experimental
Consumes alcohol
Intervention: Alcoholic beverage (Drug)
Outcomes
Primary Outcomes
Alcohol-Associated Ocular Impairments
Time Frame: 1 hour after alcohol consumption
Number of participants and measurement of Lack of Smooth Pursuit, Horizontal Gaze Nystagmus at Maximum Deviation, Horizontal Gaze Nystagmus with Onset Prior to 45-Degrees, and Vertical Gaze Nystagmus were evaluated before and after alcohol consumption.
Secondary Outcomes
- Non-Alcohol Associated Ocular Impairments(1 hour after Alcohol consumption)