- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06115915
AIVertigo: AIVertigo: Automated Differential Diagnosis of Vertigo Using Video-oculography and Advanced Artificial Intelligence-based Triage
AIVertigo: Automated Differential Diagnosis of Vertigo Using Video-oculography and Advanced Artificial Intelligence-based Triage
Study Overview
Status
Conditions
Detailed Description
Investigators analyze the VOG and vHIT data of vertigo patients in the dizziness clinics of two medical institutions: Shuang Ho Hospital (SHH) between June 2020 and June 2021 and Taichung Tzu Chi Hospital (TTCH) between July 2019 and August 2020, respectively. The institutional review boards of SHH (TMU-JIRB No. N202005118) and TTCH (REC 109-64) approved the study. All patients received structuralized history taking, neurological examinations, neuro-otological examinations, VOG and vHIT. All patients who had focal neurological symptoms/signs or central vestibular/oculomotor signs underwent brain MRI. Final diagnoses were conducted after the comprehensive studies above. The patients who did not finish VOG tests or vHIT or who had invalid data in VOG or vHIT, as well as those with uncertain final diagnoses, were excluded from the study.
According to the final diagnoses, all patients were further classified into "benign vertigo" and "dangerous vertigo" groups as the reference standard of this study. Benign vertigo is defined as vertigo that is not caused by any serious underlying condition and is generally considered harmless or self-limiting. It includes all peripheral-type vertigo and "benign" central-type vertigo without structural lesions in the brain, such as vestibular migraine and persistent postural-perceptual dizziness. However, dangerous vertigo is defined as the vertigo that is caused by a potentially severe or life-threatening underlying condition that requires immediate medical attention and intervention. It includes central-type vertigo with compatible structural lesions in the brain MRI, vertebrobasilar insufficiency with compatible stenotic arteries in MRI, and cerebellar degeneration with brain atrophy in MRI or apparent cerebellar ataxia. The classification of benign or dangerous vertigo was performed by two neurologists with expertise in dizziness and vertigo at each medical institution (SHH and TTCH) after they reviewed the clinical information and final diagnoses. In case they had differing opinions, they reached a consensus via video conferences. Otherwise, the clinical workflow was in accordance with the standard procedures of each medical institution.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
New Taipei City, Taiwan, 23561
- Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Dizziness receiving medical treatment at the Neurology and Otolaryngology departments' outpatient clinics including cases transferred from the emergency department to outpatient clinics.
- Inpatient wards (including cases transferred from the emergency department to hospitalization) of the Neurology and Otolaryngology departments.
Exclusion Criteria:
- With prosthetic eyes.
- Uncorrected visual acuity below 0.1.
- Severe hearing or cognitive impairments preventing examination.
- Severe cervical spine conditions precluding examination.
- Unable to sit for prolonged periods.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance Indices
Time Frame: 2 hour per individual
|
|
2 hour per individual
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020061901SAMD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vertigo
-
Dent Neuroscience Research CenterUniversity at BuffaloCompletedMeniere's Disease | Ménière's Vertigo | Vertigo, Intermittent | Vertigo, AuralUnited States
-
Dent Neuroscience Research CenterCures Within Reach; Dent Family FoundationRecruitingMeniere Disease | Ménière's Vertigo | Vertigo, Intermittent | Vertigo, AuralUnited States
-
Chonbuk National UniversityUnknownBenign Paroxysmal Positional Vertigo (BPPV)Korea, Republic of
-
Riphah International UniversityCompletedBenign Paroxysmal Positional Vertigo (Disorder)Pakistan
-
Chiang Mai UniversityUnknown
-
Norfolk and Norwich University Hospitals NHS Foundation...Guy's and St Thomas' NHS Foundation Trust; University Hospitals, Leicester; University... and other collaboratorsRecruitingVestibular Migraine | Benign Paroxysmal Positional Vertigo (BPPV) | Ménière's DiseaseUnited Kingdom
-
University of ZurichCompletedBenign Paroxysmal Positional VertigoSwitzerland
-
Xi'an No.3 HospitalRecruitingBenign Paroxysmal Positional VertigoChina
-
Dr. Mohammad Abu ShapheCompletedBenign Paroxysmal Positional VertigoSaudi Arabia
-
Aalborg University HospitalCompleted