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CompletedNCT07126938AAIUpdated Aug 26, 2025

Alcohol Impairment Detection in Healthy Adult Users With the Gaize Device

An observational study in Alcohol Impairment, Nystagmus and Virtual Reality, sponsored by Gaize. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-26.

Sponsored by Gaize · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
80
Ages
21 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Alcohol
  • Impairment
  • Intoxication
  • Impairment Detection Technology
  • Alcohol intoxication
  • Ocular
03

In context

Nystagmus, Pathologic

27 studies on the registry are indexed under Nystagmus, Pathologic; 3 are open to participants now.

Browse Nystagmus, Pathologic studies →

Lead sponsor

Gaize is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged between 21 and 45, having given written 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
80 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • experimental

    Consumes alcohol

    Drug: Alcoholic beverage

  • control

    Does Not Consume Alcohol

Interventions

  • DrugAlcoholic 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.

    Also known as: Alcohol, Ethanol

06

What researchers measure

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.

    Time frame: 1 hour after alcohol consumption

Secondary outcomes

  1. 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.

    Time frame: 1 hour after Alcohol consumption

07

Study locations

1 site
  • Gaize, Inc.
    Missoula, Montana 59804, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2024 to primary completion in Nov 2024, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2025
First posted
Aug 17, 2025
StartActual
Mar 21, 2024
Primary completionActual
Nov 22, 2024
CompletionActual
Nov 22, 2024
Last update
Aug 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07126938
Lead sponsor
Gaize
Responsible party
Sponsor
First posted
Aug 17, 2025
Start date
Mar 21, 2024
Primary completion
Nov 22, 2024
Completion
Nov 22, 2024
Last update
Aug 26, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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