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临床试验/NCT06115915
NCT06115915已完成不适用

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

Neurobit Technologies Co., Ltd.1 个研究点 分布在 1 个国家目标入组 391 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
391
试验地点
1
主要终点
Performance Indices

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • With prosthetic eyes.
  • Uncorrected visual acuity below 0.
  • Severe hearing or cognitive impairments preventing examination.
  • Severe cervical spine conditions precluding examination.
  • Unable to sit for prolonged periods.

结局指标

主要结局

Performance Indices

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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