A Phase 2 interventional study of VRT Care in Vertigo and Dizziness, sponsored by Johns Hopkins University. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Diagnostic
AVERT is a randomized controlled trial comparing video-oculography (VOG)-guided care to standard care to assess accuracy of diagnoses and initial management decisions for emergency department (ED) patients with a chief symptom of vertigo or dizziness suspected to be of vestibular cause. The trial will test the hypothesis that VOG-guided rapid triage (VRT) will accurately, safely, and efficiently differentiate peripheral from central vestibular disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the potential to improve post-treatment clinical outcomes for these patients.
AVERT is a multicenter phase 2 clinical trial comparing a novel diagnostic strategy (VRT) to standard ED diagnostic care at three performance sites. The Specific Aims are to assess diagnostic accuracy, diagnostic workup costs, and estimate the short-term impact of correct diagnosis in anticipation of a larger, definitive phase 3 trial. Adult ED patients with a chief symptom of vertigo, dizziness, or unsteadiness, new or clearly worse in the previous 30 days, will undergo on-site vestibular function tests by trained research personnel using a portable, quantitative VOG recording device. Research personnel will also record a focused symptom history and bedside hearing tests. Eligible patients with at least one pathologic vestibular eye movement finding or pathologic ataxia will be randomized to VRT or standard ED care. Patients eligible for pre-randomization testing but excluded from randomization will be slated for the Observational Arm of the study and will undergo limited 1-month and 6-month phone follow-up. The VRT arm relies on an automated algorithm to interpret VOG results, thereby determining a patient-specific clinical care pathway. For safety, all VRT-arm study participants will undergo stroke protocol MRI before release. All randomized participants will undergo confirmatory testing at one week, including vestibular specialist exam and 1.5 or 3-Tesla research MRI combining stroke and internal auditory canal protocols. All randomized participants will also undergo 1-month and 6-month phone follow-up and medical record review to confirm diagnoses. Clinical findings, ED diagnoses, diagnostic resource utilization, treatments applied, and clinical events during follow-up will be recorded. A multidisciplinary, masked expert panel will adjudicate final diagnoses.
187 studies on the registry are indexed under Vertigo; 27 are open to participants now.
This study's enrollment of 130 is above the median of 73 across 138 interventional studies indexed under Vertigo.
Browse Vertigo studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Adult (18 years and older) ED patients with all of the following (all determined pre-randomization):
Exclusion Criteria
Excluded from Pre-Randomization Screening
Unable or unsafe to participate in screening, including VOG tests (as deemed by specific pre-enrollment risk assessment questions or ED provider and/or Study Coordinator judgment) including, but not limited to:
Excluded from Randomization (Eligible for Observational Arm Follow-up)
Unable to participate fully with study follow-up (particularly MRI) including, but not limited to:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to VRT (VOG-guided Rapid Triage) care will have an algorithm-determined patient-specific diagnosis and treatment pathway in the emergency department. Participants will complete a 1-week in-person follow-up and a 1-month and 6-month phone follow-up.
Device: VRT Care
Patients randomized to Standard of Care will undergo usual emergency department care without revealing results of VOG testing. Participants will complete a 1-week in-person follow-up and a 1-month and 6-month phone follow-up.
The VOG report includes direct device output (physiologic traces, quantitative measures) plus most likely diagnosis, category, and clinical trial care pathway (peripheral, equivocal, central) instructions. The VOG report becomes part of the patient's emergency department clinical record.
Also known as: GN Otometrics (Instrumentation & Control Systems, Inc)
VRT vs. ED SOC Six-Category Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison)
Total diagnosis accuracy VRT vs. ED SOC using 30-day adjudicated final diagnoses categorized in one of six diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). VRT diagnoses were based on automated interpretation of ED index VOG tests in the context of structured medical history information and examination findings from the ED index visit (clinically supervised for safety), while ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations. Final diagnoses were based on ED index visit, 1-week, and 30-day follow-up clinical assessments. The population was limited to those with complete 1-week follow-up testing including in-person vestibular specialist exam, repeat VOG assessment, and MRI with diffusion-weighted images for ischemic stroke detection.
Time frame: 30-day follow-up time point
VRT vs. ED SOC Total Diagnostic Utilization Costs at the ED Index Visit (Primary Analysis-eligible Participants, Two-arm Comparison)
Total US dollar costs VRT vs. ED SOC for diagnostic tests and consultations obtained during the ED index visit and associated hospital admission (for those admitted at the index visit). For the VRT arm, this does not include costs of safety MRIs required by the institutional review board (IRB)-approved protocol or any tests ordered "off protocol" by ED physicians (i.e., it represents VRT-recommended utilization-based costs); however, it does include tests, consultations, or admissions ordered "on protocol" by consultants or ED physicians in the VRT "equivocal" diagnosis pathway. For the SOC arm, this includes all utilization-related costs from the ED index visit (tests, consultations, or admissions). Total costs are calculated by multiplying fixed cost estimates (2025 national average Medicare reimbursement in US dollars) by utilization rates for each ED index visit service tracked.
Time frame: 30-day follow-up time point
Participants With Short-Term Prespecified Medical Event(s) of Interest (PMEIs) After a Correct vs. Incorrect Diagnosis (Primary Analysis-eligible Participants, One-arm Comparison [SOC Arm Only])
PMEIs included ED revisits, falls, vascular events, and test or treatment complications. PMEIs occurring between the ED index visit disposition and 1-week follow-up visit (after which the two arms joined the same diagnostic pathway) were considered. Events diagnosed at ED index visit were not counted. Events newly diagnosed at 1-week follow-up or in the interval prior to 1-week follow-up were counted, regardless of relatedness to ED index dizziness symptoms, with the exception of test or treatment complications, which were required to be related directly or indirectly to the dizziness symptoms. To avoid "double counting" misdiagnoses as follow-on PMEIs pursuant to an initial misdiagnosis, 1-week stroke diagnoses not rendered at the ED index visit were not counted unless neurologic or vestibular symptoms/signs worsened after the ED index visit. Six-category accuracy was used to determine "correct" vs. "incorrect" index ED SOC diagnoses relative to 30-day adjudicated final diagnoses.
Time frame: 1-week follow-up time point
Expert VOG vs. ED SOC Six-Category Diagnosis Accuracy (Participants With a Known Final Diagnosis, One-arm Comparison [SOC Arm Only])
Total diagnosis accuracy Expert VOG vs. ED SOC using 30-day adjudicated final diagnoses categorized in one of six diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). Expert VOG diagnoses were based on masked interpretation of ED index VOG tests in the context of basic demographic and medical history information from the ED index visit, while ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations. Final diagnoses were based on ED index visit, 1-week, and 30-day follow-up clinical assessments. The SOC arm population was limited to those with known final diagnoses to avoid counting as "incorrect" cases with unknown final diagnoses after 30-day follow-up. This within-subject comparison reflects current potential accuracy of expert VOG-based tele-diagnosis and the targeted maximum diagnostic accuracy (i.e., expert level performance) for future automated algorithms, relative to current care.
Time frame: 30-day follow-up time point
VRT vs. ED SOC Stroke-No Stroke Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison)
Total diagnosis accuracy VRT vs. ED SOC using 30-day adjudicated final diagnoses categorized as stroke (any cerebrovascular event) versus no stroke (including peripheral vestibular, medical, psychiatric, or other central neurologic causes such as multiple sclerosis, traumatic brain injury, epilepsy, or anticonvulsant toxicity). "Index VRT Diagnosis" and "ED SOC Diagnosis" were compared to the "Adjudicated Final Diagnosis" based on ED index visit and 30-day follow-up clinical assessments.
Time frame: 30-day follow-up time point
| Milestone | VRT Care | Standard of Care (SOC) |
|---|---|---|
| Started | 65 | 65 |
| Completed | 57 | 56 |
| Not completed | 8 | 9 |
| Withdrew: Incomplete 1-week follow-up (excluded from primary analysis) | 8 | 9 |
Total diagnosis accuracy VRT vs. ED SOC using 30-day adjudicated final diagnoses categorized in one of six diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). VRT diagnoses were based on automated interpretation of ED index VOG tests in the context of structured medical history information and examination findings from the ED index visit (clinically supervised for safety), while ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations. Final diagnoses were based on ED index visit, 1-week, and 30-day follow-up clinical assessments. The population was limited to those with complete 1-week follow-up testing including in-person vestibular specialist exam, repeat VOG assessment, and MRI with diffusion-weighted images for ischemic stroke detection.
| Participants | VOG-guided Rapid Triage (VRT) Care | Standard of Care (SOC) Care |
|---|---|---|
| Participants with a correct ED index visit diagnosis | 24 | 18 |
| Participants with an incorrect ED index visit diagnosis | 33 | 38 |
Total US dollar costs VRT vs. ED SOC for diagnostic tests and consultations obtained during the ED index visit and associated hospital admission (for those admitted at the index visit). For the VRT arm, this does not include costs of safety MRIs required by the institutional review board (IRB)-approved protocol or any tests ordered "off protocol" by ED physicians (i.e., it represents VRT-recommended utilization-based costs); however, it does include tests, consultations, or admissions ordered "on protocol" by consultants or ED physicians in the VRT "equivocal" diagnosis pathway. For the SOC arm, this includes all utilization-related costs from the ED index visit (tests, consultations, or admissions). Total costs are calculated by multiplying fixed cost estimates (2025 national average Medicare reimbursement in US dollars) by utilization rates for each ED index visit service tracked.
| US dollars | VOG-guided Rapid Triage (VRT) Care | Standard of Care (SOC) Care |
|---|---|---|
| VRT vs. ED SOC Total Diagnostic Utilization Costs at the ED Index Visit (Primary Analysis-eligible Participants, Two-arm Comparison) | 3007.1 (2367.9 to 3646.3) | 3599.0 (2986.1 to 4211.8) |
PMEIs included ED revisits, falls, vascular events, and test or treatment complications. PMEIs occurring between the ED index visit disposition and 1-week follow-up visit (after which the two arms joined the same diagnostic pathway) were considered. Events diagnosed at ED index visit were not counted. Events newly diagnosed at 1-week follow-up or in the interval prior to 1-week follow-up were counted, regardless of relatedness to ED index dizziness symptoms, with the exception of test or treatment complications, which were required to be related directly or indirectly to the dizziness symptoms. To avoid "double counting" misdiagnoses as follow-on PMEIs pursuant to an initial misdiagnosis, 1-week stroke diagnoses not rendered at the ED index visit were not counted unless neurologic or vestibular symptoms/signs worsened after the ED index visit. Six-category accuracy was used to determine "correct" vs. "incorrect" index ED SOC diagnoses relative to 30-day adjudicated final diagnoses.
| Participants | Standard of Care (SOC) Care Trial Arm Participants With a Correct ED SOC Diagnosis | Standard of Care (SOC) Care Trial Arm Participants With an Incorrect ED SOC Diagnosis |
|---|---|---|
| Participants with zero PMEIs | 17 | 35 |
| Participants with one or more PMEIs | 1 | 3 |
Total diagnosis accuracy Expert VOG vs. ED SOC using 30-day adjudicated final diagnoses categorized in one of six diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). Expert VOG diagnoses were based on masked interpretation of ED index VOG tests in the context of basic demographic and medical history information from the ED index visit, while ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations. Final diagnoses were based on ED index visit, 1-week, and 30-day follow-up clinical assessments. The SOC arm population was limited to those with known final diagnoses to avoid counting as "incorrect" cases with unknown final diagnoses after 30-day follow-up. This within-subject comparison reflects current potential accuracy of expert VOG-based tele-diagnosis and the targeted maximum diagnostic accuracy (i.e., expert level performance) for future automated algorithms, relative to current care.
| Participants | Expert VOG Diagnosis Within SOC Care Trial Arm | ED SOC Diagnosis Within SOC Care Trial Arm |
|---|---|---|
| Participants with a correct ED index visit diagnosis | 29 | 13 |
| Participants with an incorrect ED index visit diagnosis | 22 | 38 |
Total diagnosis accuracy VRT vs. ED SOC using 30-day adjudicated final diagnoses categorized as stroke (any cerebrovascular event) versus no stroke (including peripheral vestibular, medical, psychiatric, or other central neurologic causes such as multiple sclerosis, traumatic brain injury, epilepsy, or anticonvulsant toxicity). "Index VRT Diagnosis" and "ED SOC Diagnosis" were compared to the "Adjudicated Final Diagnosis" based on ED index visit and 30-day follow-up clinical assessments.
| Participants | VOG-guided Rapid Triage (VRT) Care | Standard of Care (SOC) Care |
|---|---|---|
| Strokes: Participants with a correct ED index visit diagnosis | 5 | 4 |
| Strokes: Participants with an incorrect ED index visit diagnosis | 3 | 2 |
| Non-strokes: Participants with a correct ED index visit diagnosis | 35 | 39 |
| Non-strokes: Participants with an incorrect ED index visit diagnosis | 11 | 1 |
Collected over Up to 30 days follow-up. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VRT Care | 0/65 (0%) | 0/65 (0%) | 47/65 (72.3%) |
| Standard of Care (SOC) | 0/65 (0%) | 0/65 (0%) | 53/65 (81.5%) |
| Event | VRT Care | Standard of Care (SOC) |
|---|---|---|
| Transient increased dizziness, nausea, or vomiting during or immediately after VOG testingInjury, poisoning and procedural complications | 40/65 | 37/65 |
| Transient discomfort where the goggles sit or mild headache during or immediately after VOG testingInjury, poisoning and procedural complications | 20/65 | 17/65 |
| Transient fatigue or malaise during or immediately after VOG testingInjury, poisoning and procedural complications | 8/65 | 13/65 |
| Persistent increase in dizziness, nausea, vomiting, or gait unsteadiness after VOG testingInjury, poisoning and procedural complications | 7/65 | 11/65 |
| Transient neck discomfort during or immediately after VOG testingInjury, poisoning and procedural complications | 7/65 | 11/65 |
| Mild skin irritation (including eyelid) from sticky eyepatch or goggles foam insert for VOG testingInjury, poisoning and procedural complications | 2/65 | 5/65 |
| Age, Continuous(years) | VRT Care | Standard of Care (SOC) | Total |
|---|---|---|---|
| Mean | 58.3 ± 15.8 | 60.1 ± 14.3 | 59.2 ± 15.0 |
| Sex: Female, Male(Participants) | VRT Care | Standard of Care (SOC) | Total |
|---|---|---|---|
| Female | 36 | 32 | 68 |
| Male | 29 | 33 | 62 |
| Ethnicity (NIH/OMB)(Participants) | VRT Care | Standard of Care (SOC) | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 1 | 6 |
| Not Hispanic or Latino | 60 | 63 | 123 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | VRT Care | Standard of Care (SOC) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 9 | 10 | 19 |
| White | 48 | 52 | 100 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Region of Enrollment(Participants) | VRT Care | Standard of Care (SOC) | Total |
|---|---|---|---|
| United States | 65 | 65 | 130 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Mar 2023, 63 months.
Results were first posted in Dec 2025, 2 years 8 months after primary completion. A results delay was requested in Mar 2024.
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