Alcohol Impairment Detection in Healthy Adult Users With the Gaize Device (AAI)

An Observational Study to Facilitate the Development of an Alcohol Impairment Detection Device in Healthy Adult Alcohol Users

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 Overview

• Status: Completed
• Conditions: Virtual Reality; Impairment; Alcohol Intoxication; Intoxication; Nystagmus; Alcohol Impairment; Lack of Smooth Pursuit
• Intervention / Treatment: Drug: Alcoholic beverage

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Montana
    • Missoula, Montana, United States, 59804
      • Gaize, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
experimental; Consumes alcohol	Drug: Alcoholic beverage; 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.; Other Names: Ethanol; Alcohol
control; Does Not Consume Alcohol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Alcohol Associated Ocular Impairments	Number of participants and measurement of Lack of Convergence, and Pupillary Rebound Dilation were evaluated before and after alcohol consumption.	1 hour after Alcohol consumption

Collaborators and Investigators

• Sponsor: Gaize

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Actual): November 22, 2024
• Study Completion (Actual): November 22, 2024

Study Registration Dates

• First Submitted: August 7, 2025
• First Submitted That Met QC Criteria: August 13, 2025
• First Posted (Actual): August 17, 2025

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Alcohol; Impairment; Intoxication; Ocular; Alcohol intoxication; Impairment Detection Technology
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Eye Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Cranial Nerve Diseases; Ocular Motility Disorders; Alcoholic Intoxication; Nystagmus, Pathologic; Organic Chemicals; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Alcohols; Ethanol; Alcoholic Beverages
• Other Study ID Numbers: 23-GPHAV-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No