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临床试验/NCT03821155
NCT03821155已完成不适用

Which Treatment is Most Effective When Treating Vestibular Neuritis: Corticosteroid Treatment Alone or Combined Corticosteroid Treatment and Vestibular Rehabilitation?

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Suppressing head impulse paradigm (SHIMP)

研究概览

简要总结

To investigate which treatment option (corticosteroid treatment alone or combined corticosteroid treatment and vestibular rehabilitation) is the most effective in patients diagnosed with vestibular neuritis.

详细描述

Patients diagnosed with vestibular neuritis will we consider for enrollment. Each patient will undergo randomization for a specific treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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 above 18 years of age
  • Medical history compatible with vestibular neuritis
  • Verification of vestibular neuritis with positive romberg test, pathological v-HIT and horizontal nystagmus with a rotatory component.

排除标准

  • Former medical history with vestibular dysfunction
  • Medical history or objective signs of cochlear dysfunction before, during or after onset of vestibular neuritis
  • Onset of symptoms 14 days before recruitment to the study
  • Focal neurological symptoms/signs
  • Contraindication to prednisolone treatment
  • Problem with participating in vestibular rehabilitation due to muscular-skeletal disease ect.

研究组 & 干预措施

Neuritis vestibularis (group 1)

Active Comparator

Corticosteroid ("prednisolone")

干预措施: Corticosteroid (Drug)

Neuritis vestibularis (group 2)

Experimental

Corticosteroid ("prednisolone") + vestibular rehabilitation

干预措施: Vestibular rehabilitation (Other)

Neuritis vestibularis (group 2)

Experimental

Corticosteroid ("prednisolone") + vestibular rehabilitation

干预措施: Corticosteroid (Drug)

结局指标

主要结局

Suppressing head impulse paradigm (SHIMP)

时间窗: 6 month

SHIMP equipment will objectively quantify change of vestibular function.

Subjective visual vertical (SVV)

时间窗: 6 month

SVV test will objectively quantify the experienced spatial orientation as an indicator of visual and vestibular otolithic function

Video head impulse test (v-HIT)

时间窗: 6 month

v-HIT equipment will objectively quantify change of vestibular function.

Dizziness handicap inventory (DHI) questionnaire

时间窗: 6 month

Fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dan Dupont Hougaard

MD, Assistant Professor

Aalborg University Hospital

研究点 (1)

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