AIVertigo: AIVertigo: Automated Differential Diagnosis of Vertigo Using Video-oculography and Advanced Artificial Intelligence-based Triage

NCT06115915 | Completed

• 1 other identifier: 2020061901SAMD
• Study Type: observational
• Target: 391
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vertigo

Keywords

Vertigo; Videonystagmography (VNG); Software as Medical Device (SaMD); Computer-Aided Triage and Notification (CADt); Artificial Intelligence/Machine Learning (AI/ML)

Outcome Measures

Primary Outcomes (1)

• Performance Indices

  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

  2 hour per individual

Eligibility Criteria

• Age: 20 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurobit Technologies Co., Ltd.: lead
• Taipei Medical University: collaborator
• Buddhist Tzu Chi Medical Foundation: collaborator

Study Sites (1)

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, 23561, Taiwan

Location

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2023
• First Posted: November 3, 2023
• Study Start: July 1, 2019
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

TW (1)