Alcohol ImpairmentAAINCT07126938
Alcohol Impairment Detection in Healthy Adult Users With the Gaize Device
An observational study of Alcohol Impairment and Nystagmus, run by Gaize at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Impairment, Nystagmus, Virtual Reality
- What is being tested?
- Alcoholic beverage
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2024to 22 Nov 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alcohol Impairment, Nystagmus, Virtual Reality, Lack of Smooth Pursuit, Impairment, Alcohol Intoxication
- Being tested
- Alcoholic beverage
- Keywords
- Alcohol, Impairment, Intoxication, Impairment Detection Technology, Alcohol intoxication, Ocular
- Medical subject headings
- Nystagmus, Pathologic, Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcoholic beverageDrug
Also called Alcohol, Ethanol
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Consumes alcohol Receives: Drug: Alcoholic beverage | |
| control | Does Not Consume Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 hour after Alcohol consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start21 Mar 2024
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gaize
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126938
- Sponsor's protocol ID
- 23-GPHAV-01
- Acronym
- AAI
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Facilitate the Development of an Alcohol Impairment Detection Device in Healthy Adult Alcohol Users
- ClinicalTrials.gov ID
- NCT07126938
- Acronym / sponsor ID
- AAI / 23-GPHAV-01
- Conditions
- Alcohol Impairment, Nystagmus, Virtual Reality, Lack of Smooth Pursuit, Impairment, Alcohol Intoxication
- Keywords
- Alcohol, Impairment, Intoxication, Impairment Detection Technology, Alcohol intoxication, Ocular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- GaizeIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | – | Drug: Alcoholic beverageConsumes alcohol |
| control | – | –Does Not Consume Alcohol |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcoholic beverageAlso: Alcohol, EthanolParticipants 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. | Drug | experimental |
Primary outcome
Alcohol-Associated Ocular Impairments
Time frame: 1 hour after alcohol consumption
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 secondary outcome
Non-Alcohol Associated Ocular Impairments
Time frame: 1 hour after Alcohol consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Alcohol Impairment
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Not yet recruitingPhase 1
The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin
Psilocybin Intoxication
Active, not recruitingPhase 1
rTMS in Older Adults With MCI and AUD
Alcohol Use Disorder, Mild Cognitive Impairment
RecruitingPhase 1
Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
Cannabis Intoxication, Alcohol Intoxication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Impairment and Nystagmus, run by Gaize at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol-Associated Ocular Impairments (time frame: 1 hour after alcohol consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.