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临床试验/NCT04935970
NCT04935970Unknown不适用

Metabolic Disorders and Their Correction in Vertigo and Unsteadiness

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
hyperhomocysteinaemia reveal

研究概览

简要总结

The purpose of investigation is to assess the levels of metabolic factors (hydroxyvitamin D, homocysteine) between patients with vestibular dysfunction of peripheral origin (BPPV) and central origin (vestibular migraine). Also we will analyse another factors (such as anxiety and depression) and optimize therapeuthical approach accordingly with the data.

详细描述

Dizziness causes up to 2 to 15% of primary neurological complaints. In some patients who have undergone acute vertigo, postural instability, persistent postural perceptual vertigo (PPPV) develops, while in other similar cases occurs full recovery. So, it is necessary to search for neurophysiological, metabolic and psychophysiological factors and associated premorbid conditions that affect the outcome of neurovestibular compensation.

The case-control study will include 2 groups of patients suffering from vertigo of central and peripherial etiology. First group is recruited with patients were diagnosed with peripherial vestibular disorders, such as benign paroxysmal positional vertigo (BPPV), Meniere disease, vestibular neuritis. The proposal number of subjects in the first group is about forty. The second group will consist of forty patients with central vestibular disfunction: vestibular migraine, central positional vertigo etc. The inclusion of patient with persistent postural perceptual dizziness is discussed. Patients will be tested for hydroxyvitamin D and homocysteine in serum using an enzyme-linked immunosorbent assay (ELISA). The perception of the severity of disability was assessed using the Dizziness scale Handicap Inventory (DHI). All patients will undergo psychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'sscale. Statistical analysis was carried out with the Statistical Analysis System (SAS) package. The relationships will be assessed using the chi squared test and logistic regression. The level of significance is set at p < 0.05. The methods for small samples (Mann-Whitney U ) will be used. It is presumed that differences in vitamin D levels beetween two groups will be considerable.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent of participation in the study;
  • Age:over 18 years old
  • complaints of dizziness and insteadiness

排除标准

  • Severe cognitive impairment (dementia)
  • Severe depression
  • Syncopal paroxysms
  • Epileptic seizures
  • Orthostatic hypotension
  • Severe arrhythmia, unstable angina pectoris, acute myocardial infarction
  • Pregnancy
  • Alcoholism, substance abuse and drug addiction
  • Organic liver and kidney diseases with the development of functional disorders.
  • Anemia (hemoglobin <10.5 g / dl for women and <11.5 g / dl for men)
  • Active oncological process
  • Demyelinating and neurodegenerative diseases.

结局指标

主要结局

hyperhomocysteinaemia reveal

时间窗: Through 1-6 months of diagnosis established.

enzyme-linked immunosorbent assay (ELISA).

vitamin D deficiency/insufficiency reveal

时间窗: Through 1-6 months of diagnosis established.

enzyme-linked immunosorbent assay (ELISA).

次要结局

  • correlation between metabolic and neuropsychological disorders(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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