An investigation into the diagnostic accuracy, reliability, acceptability and safety of a novel device for Continuous Ambulatory Vestibular Assessment (CAVA)
An investigation into the diagnostic accuracy, reliability, acceptability and safety of a novel device for Continuous Ambulatory Vestibular Assessment (CAVA)
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DOI：
10.1038/s41598-019-46970-7
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发表时间：
2019-07-18
影响因子：
4.6
通讯作者：
Cox, Stephen J.
中科院分区：
文献类型：
--
作者：
Phillips, John S.;Newman, Jacob L.;Cox, Stephen J.
头晕是一种常见病症，会造成很大程度的物质发病率和卫生服务负担。它通常是偶发性且短暂的，因此当患者就诊于临床医生时，检查是正常的。 CAVA（连续动态前庭评估）设备旨在提供眼球运动的连续监测，从而深入了解头晕发作期间出现的生理参数。本文描述了对这种新诊断系统的医学和技术方面的首次临床研究。十七名健康受试者几乎连续佩戴该设备长达三十天，其中八次人为诱发眼球震颤。捕获了 405 天的数据，包括约 40 亿个数据点。为检测眼球震颤而开发的计算机算法显示出 99.1% 的敏感性（95% CI：95.13% 至 99.98%）和 98.6% 的特异性（95% CI：96.54% 至 99.63%）。 82% 的参与者每天至少有 80% 的时间佩戴该设备。不良事件是自限性的，主要是由于每天更换电极导致皮肤剥落的结果。该设备被证明可以作为动态监测器有效运行，可以可靠地检测人工诱发的眼球震颤。
Dizziness is a common condition that is responsible for a significant degree of material morbidity and burden on health services. It is usually episodic and short-lived, so when a patient presents to their clinician, examination is normal. The CAVA (Continuous Ambulatory Vestibular Assessment) device has been developed to provide continuous monitoring of eye-movements, allowing insight into the physiological parameters present during a dizziness attack. This article describes the first clinical investigation into the medical and technical aspects of this new diagnostic system. Seventeen healthy subjects wore the device near continuously for up to thirty days, artificially inducing nystagmus on eight occasions. 405 days' worth of data was captured, comprising around four billion data points. A computer algorithm developed to detect nystagmus demonstrated a sensitivity of 99.1% (95% CI: 95.13% to 99.98%) and a specificity of 98.6% (95% CI: 96.54% to 99.63%). Eighty-two percent of participants wore the device for a minimum of eighty percent of each day. Adverse events were self-limiting and mostly the consequence of skin stripping from the daily replacement of the electrodes. The device was shown to operate effectively as an ambulatory monitor, allowing the reliable detection of artificially induced nystagmus.