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临床试验/NCT05984901
NCT05984901已完成不适用

Continuous Ambulatory Vestibular Assessment (CAVA): Development of a System to Provide an Automatic Diagnosis for Vestibular Conditions

Norfolk and Norwich University Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Success of a diagnostic device to diagnose different inner-ear conditions

研究概览

简要总结

The CAVA trial is a diagnostic accuracy multicentre device trial which aims to quantify the extent to which the CAVA system can differentiate three common inner-ear causes of dizziness: Ménière's disease, vestibular migraine and Benign Paroxysmal Positional Vertigo (BPPV).

The CAVA device is composed of two components: a set of bespoke single-use sensor arrays that adhere to the left and right side of the participant's face; and a small reusable module fitting over the ear that contains a battery, microcomputer data storage facility and connection ports for the arrays. The CAVA device will be worn by all participants for 30 days with the aim of capturing eye movement data during a dizzy attack.

The first objective is to develop an algorithm that can discriminate between the 3 listed dizziness conditions. The second is to quantify the financial and patient benefits of deployment in the NHS. The final objective is to expedite a plan to deploy the system in the NHS.

详细描述

This is a multicentre diagnostic accuracy study with a recruitment target of 255 adult participants. Recruitment will take place across ten sites in the UK, over two years. To be eligible, participants must have an existing diagnosis of Ménière's disease, vestibular migraine or BPPV. The study will recruit eighty-five participants with each condition. Each patient's diagnosis will form the "reference standard" which will later be compared with a automated computer diagnosis.

Each participant will wear the CAVA device near continuously for thirty days. The device will record all eye and head movements during this time, including during any episodes of vertigo. When a patient experiences an episode of vertigo, they will be asked to activate an event marker on the CAVA device and keep a written record of attack onset and duration in a diary. Although this manual logging will not be relied upon for algorithm development, the whole 30 days of data will be used to detect periods of eye movement associated with dizziness.

The investigators will develop computer algorithms that use the data captured by the CAVA devices to differentiate between three target conditions. These algorithms will build on the algorithms that have been developed during the current MRC grant which have produced excellent results.10,11,17. The algorithms use deep learning neural networks (DNNs) in a so-called 'end-to-end' approach. In this approach, a multi-layered network takes as input 'raw' time domain data and outputs a classification decision without using any explicit intermediate representations of the signal (such as signal entropy, power, skewness, kurtosis etc.). End-to-end approaches, which typically utilise alternating sequences of convolution and pooling layers, fully connected layers, auto-encoders and long short-term memory (LSTM) layers, have been shown to outperform traditional approaches in cases where large amounts of training data are available. However, they provide little insight into how they work (i.e., which features of the signal are important for classification). It will therefore also be considered to develop methods in which intermediate representations are generated and then use these input features to test a range of classifiers (e.g., boosted trees, random forests, logistic regression, support vector machines etc.).

The performance of the algorithms will be assessed using the 'leave-one-out cross-validation' technique, which is the usual way of evaluating classifiers.22 In this technique, the data from a single patient is set aside and the remaining data from the other patients is used to 'train' the classifier. A algorithm will be referred to that is trained to distinguish the three conditions as a 'classifier'. The classifier is then tested on the set aside data: the testing process consists of comparing the classifier's predicted diagnosis ('Ménière's disease', 'vestibular migraine' or 'BPPV') with the true diagnosis (the reference standard label). This process is repeated, removing a different patient's data each time, producing an automated diagnosis for all 255 patients. Although computationally expensive, this ensures that the classifier has not 'seen' during training the data from the patient it tests, which would bias its decision. It also closely matches the real-world scenario of a new patient presenting to their clinician and a diagnosis being provided on the basis of their experience of other patients.

The study will present the sensitivity and specificity for diagnosing each of the three target conditions and Receiver Operator Curves (ROCs), showing how the diagnostic accuracy changes for various classification thresholds.

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

  • Age 18 and over
  • Must have relevant index medical condition: Ménière's Disease, Vestibular Migraine, posterior canal Benign Paroxysmal Positional Vertigo (see section 6.3.1.2 for specific criteria)
  • Experiencing episodes of true vertigo with at least 2 episodes within the preceding 4 weeks at time of consent
  • The duration and nature of the vertigo is of a duration and a nature supportive of the relevant index medical condition
  • Owns and able to use a telephone
  • Willing to provide informed consent
  • Willing to comply with the study protocol for using the CAVA device
  • Willing to complete all study materials
  • Adequate grasp of the English language or language used within an existing translated version of the informed consent form and patient information sheet and where hospital translators are available to provide support

排除标准

  • Has an allergy to plasters and/or medical adhesives
  • Evidence of dermatitis, fragile skin, or any other condition that could be aggravated by the repeated application of skin surface adhesives
  • Pregnant or breastfeeding mothers
  • Bilateral or second side Ménière's Disease
  • Active bilateral or second side posterior canal Benign Paroxysmal Positional Vertigo
  • Currently enrolled on an intervention trial (not including questionnaire-based or observational trial)
  • Patients who meet diagnostic criteria for more than one eligible condition at time of recruitment

研究组 & 干预措施

The CAVA Multicentre Dizziness Trial (CAVA2)

Other

CAVA 2 is a single arm study testing a diagnostic device to diagnose different inner-ear conditions appraised by calculating values for sensitivity and specificity. Head and eye movements recorded by the CAVA device will enable the computer algorithms (to be developed) to differentiate between the three target conditions.

干预措施: The continuous ambulatory vestibular assessment (CAVA) system (Device)

结局指标

主要结局

Success of a diagnostic device to diagnose different inner-ear conditions

时间窗: 30 Days

The primary outcome is the success of a diagnostic device to diagnose different inner-ear conditions appraised by calculating values for sensitivity and specificity. Head and eye movements recorded by the CAVA device will enable the computer algorithms (to be developed) to differentiate between the three target conditions. The investigators will develop computer algorithms that use the data captured by the CAVA devices to differentiate between the three target conditions. The algorithms use deep learning neural networks (DNNs) in a so-called 'end-to-end' approach. In this approach, a multi-layered network takes as input 'raw' time domain data and outputs a classification decision without using any explicit intermediate representations of the signal (such as signal entropy, power, skewness, kurtosis etc.)

次要结局

  • Health economics data(30 Days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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