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临床试验/NCT02938221
NCT02938221已完成不适用

Feasibility and Safety of a Telemedically Performed Three-Component Oculomotor Testing Battery (HINTS) in Healthy Adults

Munich Municipal Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Number of evaluable telemedical oculomotor examinations

研究概览

简要总结

The study investigates the feasibility and safety of the telemedical implementation of three diagnostic oculomotor tests using a video-oculography device and an extended teleconferencing system. The testing battery comprises Halmagyi's head impulse test, test for nystagmus and test of skew (vertical misalignment) known as the HINTS protocol. Previously published data have shown high sensitivity and specificity of the protocol for the discrimination of central and peripheral causes of acute vestibular syndrome. In this study the three tests will be executed on 30 healthy subjects using video goggles (EyeSeeCam, Interacoustics GmbH, Germany) connected to a mobile wireless-workstation for bidirectional audiovisual communication in a clinical environment (MEYTEC GmbH, Germany). A newly developed remote control and video conferencing solution allows the execution and evaluation of the HINTS protocol in a telemedical setup.

The examination is guided by a remote physician using the help of a trained assistant attending to the subject. Corresponding clinical bedside tests will be executed for comparison. Primary endpoint is feasibility of the three diagnostic tests in a telemedical setting. Safety as well as accuracy of the telemedical versus bedside examination will be analyzed as secondary outcome measures. Aim of the study is to improve diagnostic accuracy for patients with acute vestibular syndrome in remote areas where specialists are rare.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Consenting adults

排除标准

  • Acute vertigo or dizziness, acute neck pain, history of stroke, history of acute vestibular syndrome, strong unilateral or bilateral visual impairment, complete movement restriction of cervical spine

结局指标

主要结局

Number of evaluable telemedical oculomotor examinations

时间窗: through completion of diagnostic test, an average of 10 minutes

次要结局

  • Number of participants with adverse or serious adverse events that are related to telemedical oculomotor examination(through completion of diagnostic test, an average of 10 minutes)
  • Time delay of telemedical tests(through completion of diagnostic test, an average of 10 minutes)
  • Accuracy of telemedical oculomotor examination (correlation to bedside test)(through completion of diagnostic test, an average of 10 minutes)

研究者

发起方
Munich Municipal Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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