VertigoNCT06115915
AIVertigo: AIVertigo: Automated Differential Diagnosis of Vertigo Using Video-oculography and Advanced Artificial Intelligence-based Triage
An observational study of Vertigo, run by Neurobit Technologies Co., Ltd. at 1 site in Taiwan.
Trial summary
The eye movement records and vestibular pulse examinations obtained from patients with dizziness can provide characteristic parameters and features of eye movements and vestibular reflexes. These can assist specialized physicians in diagnosing various forms of dizziness disorders. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Vertigo
- How many people
- 391 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2019to 18 Jun 2021
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with dizziness who seek treatment at the Neurology or Otolaryngology outpatient clinics or are admitted to Shuang Ho Hospital are potential candidates for enrollment. Patients who meet the inclusion criteria and have the research purpose and process explained by a physician or research assistant, agree to participate in this study, and complete the informed consent form will be considered eligible for enrollment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, 23561
About this study
Official title: AIVertigo: Automated Differential Diagnosis of Vertigo Using Video-oculography and Advanced Artificial Intelligence-based Triage
The eye movement records and vestibular pulse examinations obtained from patients with dizziness can provide characteristic parameters and features of eye movements and vestibular reflexes. These can assist specialized physicians in diagnosing various forms of dizziness disorders. Through extensive analysis of databases, a disease prediction model can be established, significantly lowering the diagnostic barriers for non-specialist doctors, thereby enabling their diagnostic capabilities to approach that of experts.
Read the 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.
- Conditions
- Vertigo
- Keywords
- Vertigo, Videonystagmography (VNG), Software as Medical Device (SaMD), Computer-Aided Triage and Notification (CADt), Artificial Intelligence/Machine Learning (AI/ML)
- Medical subject headings
- Vertigo
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Indices
- Sensitivity, specificity, positive predictive value, and negative predictive value of combined parameters of eye movement and vestibular reflex in screening various types of vestibular disorders.
- Sensitivity, specificity, positive predictive value, and negative predictive value of combined parameters of eye movement and vestibular reflex in screening various types of vestibular disorders cross different medical institution
Measured: 2 hour per individual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Jul 2019
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurobit Technologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University, Buddhist Tzu Chi Medical Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115915
- Sponsor's protocol ID
- 2020061901SAMD
- Status last verified
- Nov 2023
- First submitted
- 28 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIVertigo: Automated Differential Diagnosis of Vertigo Using Video-oculography and Advanced Artificial Intelligence-based Triage
- ClinicalTrials.gov ID
- NCT06115915
- Acronym / sponsor ID
- 2020061901SAMD
- Conditions
- Vertigo
- Keywords
- Vertigo, Videonystagmography (VNG), Software as Medical Device (SaMD), Computer-Aided Triage and Notification (CADt), Artificial Intelligence/Machine Learning (AI/ML)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Neurobit Technologies Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University, Buddhist Tzu Chi Medical Foundation
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 3 Nov 2023 (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.
The eye movement records and vestibular pulse examinations obtained from patients with dizziness can provide characteristic parameters and features of eye movements and vestibular reflexes. These can assist specialized physicians in diagnosing various forms of dizziness disorders. Through extensive analysis of databases, a disease prediction model can be established, significantly lowering the diagnostic barriers for non-specialist doctors, thereby enabling their diagnostic capabilities to approach that of experts.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dizziness who seek treatment at the Neurology or Otolaryngology outpatient clinics or are admitted to Shuang Ho Hospital are potential candidates for enrollment. Patients who meet the inclusion criteria and have the research purpose and process explained by a physician or research assistant, agree to participate in this study, and complete the informed consent form will be considered eligible for enrollment.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance Indices
Time frame: 2 hour per individual
1. Sensitivity, specificity, positive predictive value, and negative predictive value of combined parameters of eye movement and vestibular reflex in screening various types of vestibular disorders. 2. Sensitivity, specificity, positive predictive value, and negative predictive value of combined parameters of eye movement and vestibular reflex in screening various types of vestibular disorders cross different medical institution
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 3 Nov 2023.
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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 Vertigo, run by Neurobit Technologies Co., Ltd. at 1 site in Taiwan.
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 2 inclusion and 5 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 3 Nov 2023. 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 Taiwan. 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?
Performance Indices (time frame: 2 hour per individual). 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 3 Nov 2023.