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

Completed

• Conditions: Alcohol Impairment; Alcohol Intoxication; Nystagmus; Virtual Reality; Lack of Smooth Pursuit; Impairment; Intoxication
• Interventions: Drug: Alcoholic beverage

• Registration Number: NCT07126938
• Lead Sponsor: Gaize

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-21
• Primary Completion: 2024-11-22
• Study Completion: 2024-11-22
• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
experimental	Alcoholic beverage	Consumes alcohol

Primary Outcome Measures

Name	Time	Method
Alcohol-Associated Ocular Impairments	1 hour after alcohol consumption	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 Outcome Measures

Name	Time	Method
Non-Alcohol Associated Ocular Impairments	1 hour after Alcohol consumption	Lack of Convergence, and Pupillary Rebound Dilation were evaluated before and after alcohol consumption.

Trial Locations

Locations (1)

Gaize, Inc.; 🇺🇸 Missoula, Montana, United States