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临床试验/NCT05922774
NCT05922774招募中不适用

Evaluation of Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
The comparison of cVEMP findings in normal controls and BPPV patients with nonrecurrent and recurrent BPPV symptoms after 4 week follow-up.

研究概览

简要总结

The goal of this observational study is to compare the cervical vestibular evoked myogenic potentials in recurrent/persistant BPPV and nonrecurrent BPPV. Recurrent/persistant BPPV is considered as the patients who require more than one repositioning manuever for the resolution of symptoms and the recurrent cases in the first three months after the diagnosis.

The main question[s] it aims to answer are:

  • Is there any difference between the cVEMP findings of diseased ears of recurrent and nonrecurrent BPPV cases?
  • Is there any difference between the cVEMP findings of diseased ears and healthy ears of BPPV patients
  • Is there any difference between the cVEMP findings of healthy ears of recurrent and nonrecurrent BPPV cases and healthy controls?

Patients with VNG confirmed BPPV will be recruited and CVEMP test will be performed before the therapeutic manuevers.

Control visits will be scheduled on the 7th day after the therateutic menuevers are performed.

Patients will be followed-up for 4 weeks after the resolution of symptoms. Researchers will compare recurrent (Group 1), nonrecurrent (group 2) BPPV patients and healthy controls (Group 3) to see if there is any difference between the cVEMP findings of two groups.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to ENT clinic with unilateral posterior or lateral canal BPPV for the first time

排除标准

  • patients with bilateral BPPV
  • patients with recurrent or resistant BPPV
  • patients with spontaneous nystagmus
  • vestibular or neurologic disorders other than BPPV
  • patients who use medication which may affect the vestibular system or muscle tone
  • cervical muscle disorders and ocular pathologies which may affect the VEMP results

结局指标

主要结局

The comparison of cVEMP findings in normal controls and BPPV patients with nonrecurrent and recurrent BPPV symptoms after 4 week follow-up.

时间窗: 13 weeks

Patients with VNG confirmed BPPV will be recruited and CVEMP test will be performed before the therapeutic manuevers. Control visits will be scheduled on the 7th day after the therapeutic menuevers are performed. Patients will be followed-up for 4 weeks after the resolution of symptoms. Researchers will compare recurrent (Group 1), nonrecurrent (group 2) BPPV patients and healthy controls (Group 3) to see if there is any difference between the cVEMP findings of these groups.

次要结局

未报告次要终点

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ISIL TAYLAN CEBI

principal investigator

Haseki Training and Research Hospital

研究点 (1)

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