NCT07126938

Alcohol Impairment Detection in Healthy Adult Users With the Gaize Device

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Gaize · Industry
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-21
• Primary completion: 2024-11-22
• Completion: 2024-11-22
• First posted: 2025-08-17
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States