Alcohol Impairment Detection in Healthy Adult Users With the Gaize Device

NCT07126938 | Completed

• 1 other identifier: 23-GPHAV-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Impairment; Nystagmus; Virtual Reality; Lack of Smooth Pursuit; Impairment; Alcohol Intoxication; Intoxication

Keywords

Alcohol; Impairment; Intoxication; Impairment Detection Technology; Alcohol intoxication; Ocular

Outcome Measures

Primary Outcomes (1)

• Alcohol-Associated Ocular Impairments

  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.

  1 hour after alcohol consumption

Secondary Outcomes (1)

• Non-Alcohol Associated Ocular Impairments

  1 hour after Alcohol consumption

Study Arms (2)

experimental

Consumes alcohol

Drug: Alcoholic beverage

control

Does Not Consume Alcohol

Interventions

Alcoholic beverage DRUG

Participants in the experimental group consumed self-selected amounts of alcohol, monitored by study staff to ensure safety and compliance with protocol guidelines. Participants then filled out the remainder of the general health questionnaire, including how many drinks they consumed, and whether or not they feel too impaired to drive a vehicle or go to work.

Also known as: Alcohol, Ethanol

experimental

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Age: Participants ranged from 21 to 45 years old, with an average age of 28.5 years (SD = 6.2). * Gender Distribution: The study included 60% male and 40% female participants. * Race: The sample was predominantly White (70%), followed by Asian (20%), and Black or other races (10%). * Weight: Participant weights ranged from 120 lbs to 250 lbs, with an average weight of 180 lbs (SD = 35 lbs).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaize: lead

Study Sites (1)

Gaize, Inc.

Missoula, Montana, 59804, United States

Location

MeSH Terms

Conditions

Nystagmus, Pathologic; Alcoholic Intoxication

Interventions

Alcoholic Beverages; Ethanol

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Alcohols; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 17, 2025
• Study Start: March 21, 2024
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (1)