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NCT02483429: AVERT

Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)

Completed Phase 2 Results posted Last updated 26 December 2025
What this trial tests

Phase 2 trial testing VRT Care in Vertigo in 130 participants. Completed in 17 March 2023.

Timeline
4 December 2017
Primary endpoint
17 March 2023
17 March 2023

Quick facts

Lead sponsorJohns Hopkins University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposediagnostic
Enrollment130
Start date4 December 2017
Primary completion17 March 2023
Estimated completion17 March 2023
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Vertigo or Dizziness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

VRT vs. ED SOC Six-Category Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison) Primary · 30-day follow-up time point

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

Participants with a correct ED index visit diagnosis
GroupValue95% CI
VOG-guided Rapid Triage (VRT) Care24
Standard of Care (SOC) Care18
Participants with an incorrect ED index visit diagnosis
GroupValue95% CI
VOG-guided Rapid Triage (VRT) Care33
Standard of Care (SOC) Care38
VRT vs. ED SOC Total Diagnostic Utilization Costs at the ED Index Visit (Primary Analysis-eligible Participants, Two-arm Comparison) Primary · 30-day follow-up time point

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 ar

GroupValue95% CI
VOG-guided Rapid Triage (VRT) Care3007.12367.9 – 3646.3
Standard of Care (SOC) Care3599.02986.1 – 4211.8
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]) Primary · 1-week follow-up time point

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

Participants with zero PMEIs
GroupValue95% CI
Standard of Care (SOC) Care Trial Arm Participants With a Correct ED SOC Diagnosis17
Standard of Care (SOC) Care Trial Arm Participants With an Incorrect ED SOC Diagnosis35
Participants with one or more PMEIs
GroupValue95% CI
Standard of Care (SOC) Care Trial Arm Participants With a Correct ED SOC Diagnosis1
Standard of Care (SOC) Care Trial Arm Participants With an Incorrect ED SOC Diagnosis3
Expert VOG vs. ED SOC Six-Category Diagnosis Accuracy (Participants With a Known Final Diagnosis, One-arm Comparison [SOC Arm Only]) Secondary · 30-day follow-up time point

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 SO

Participants with a correct ED index visit diagnosis
GroupValue95% CI
Expert VOG Diagnosis Within SOC Care Trial Arm29
ED SOC Diagnosis Within SOC Care Trial Arm13
Participants with an incorrect ED index visit diagnosis
GroupValue95% CI
Expert VOG Diagnosis Within SOC Care Trial Arm22
ED SOC Diagnosis Within SOC Care Trial Arm38
VRT vs. ED SOC Stroke-No Stroke Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison) Secondary · 30-day follow-up time point

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.

Strokes: Participants with a correct ED index visit diagnosis
GroupValue95% CI
VOG-guided Rapid Triage (VRT) Care5
Standard of Care (SOC) Care4
Strokes: Participants with an incorrect ED index visit diagnosis
GroupValue95% CI
VOG-guided Rapid Triage (VRT) Care3
Standard of Care (SOC) Care2
Non-strokes: Participants with a correct ED index visit diagnosis
GroupValue95% CI
VOG-guided Rapid Triage (VRT) Care35
Standard of Care (SOC) Care39
Non-strokes: Participants with an incorrect ED index visit diagnosis
GroupValue95% CI
VOG-guided Rapid Triage (VRT) Care11
Standard of Care (SOC) Care1

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 30 days follow-up. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

VRT Care
Serious: 0/65 (0%)
Deaths: 0/65
Standard of Care (SOC)
Serious: 0/65 (0%)
Deaths: 0/65
Other adverse events (6 terms — click to expand)

ReactionSystemVRT CareStandard of Care (SOC)
Transient increased dizziness, nausea, or vomiting during or immediately after VOG testingInjury, poisoning and procedural complications
Transient discomfort where the goggles sit or mild headache during or immediately after VOG testingInjury, poisoning and procedural complications
Transient fatigue or malaise during or immediately after VOG testingInjury, poisoning and procedural complications
Persistent increase in dizziness, nausea, vomiting, or gait unsteadiness after VOG testingInjury, poisoning and procedural complications
Transient neck discomfort during or immediately after VOG testingInjury, poisoning and procedural complications
Mild skin irritation (including eyelid) from sticky eyepatch or goggles foam insert for VOG testingInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT02483429 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Diagnosing Stroke in Acute Dizziness and Vertigo: Pitfalls and Pearls.
    Saber Tehrani AS, Kattah JC, Kerber KA, Gold DR, et al · · 2018 · cited 105× · PMID 29459396 · DOI 10.1161/strokeaha.117.016979
  2. Missed stroke in acute vertigo and dizziness: It is time for action, not debate.
    Newman-Toker DE. · · 2016 · cited 104× · PMID 26418192 · DOI 10.1002/ana.24532
  3. Symptom-Disease Pair Analysis of Diagnostic Error (SPADE): a conceptual framework and methodological approach for unearthing misdiagnosis-related harms using big data.
    Liberman AL, Newman-Toker DE. · · 2018 · cited 77× · PMID 29358313 · DOI 10.1136/bmjqs-2017-007032
  4. Impact of artifacts on VOR gain measures by video-oculography in the acute vestibular syndrome.
    Mantokoudis G, Saber Tehrani AS, Wozniak A, Eibenberger K, et al · · 2016 · cited 34× · PMID 27814312 · DOI 10.3233/ves-160587
  5. The Diagnostic Performance Feedback "Calibration Gap": Why Clinical Experience Alone Is Not Enough to Prevent Serious Diagnostic Errors.
    Omron R, Kotwal S, Garibaldi BT, Newman-Toker DE. · · 2018 · cited 31× · PMID 30386846 · DOI 10.1002/aet2.10119
  6. aEYE: A deep learning system for video nystagmus detection.
    Wagle N, Morkos J, Liu J, Reith H, et al · · 2022 · cited 21× · PMID 36034311 · DOI 10.3389/fneur.2022.963968
  7. A Simple Gain-Based Evaluation of the Video Head Impulse Test Reliably Detects Normal Vestibulo-Ocular Reflex Indicative of Stroke in Patients With Acute Vestibular Syndrome.
    Machner B, Erber K, Choi JH, Sprenger A, et al · · 2021 · cited 16× · PMID 34777209 · DOI 10.3389/fneur.2021.741859
  8. Real-world virtual patient simulation to improve diagnostic performance through deliberate practice: a prospective quasi-experimental study.
    Kotwal S, Fanai M, Fu W, Wang Z, et al · · 2021 · cited 12× · PMID 33675203 · DOI 10.1515/dx-2020-0127

Verify or expand the search:

Other recruiting trials for Vertigo

Currently open trials in the same condition.

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Data sources for this page

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