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临床试验/NCT03346889
NCT03346889进行中(未招募)不适用

Vertigo Symptoms, Balance and Vestibular Function in Patients With Vestibular Schwannoma

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2017年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
155
试验地点
1
主要终点
Dizziness Handicap Inventory (DHI)

研究概览

简要总结

Previous studies have shown that vertigo is the symptoms that mostly affect quality of life in patients with vestibular schwannoma. There is still limited knowledge as to why some patients with this disorder develop vertigo, while others with the same diagnosis do not. The purpose of this study is to measure symptom-related quality of life and to relate this to objective disease characteristics at baseline.

详细描述

This is a longitudinal observational study with data collected at baseline and after treatment.

Variables collected at baseline include age, sex, tumor size, location, type (cystic/solid), tumor side, symptom variables including Dizziness Handicap Inventory, Vertigo Symptom Scale Short Form, Haukeland Dizziness Questionnaire, Visual analog scale, Hospital Anxiety and Depression Scale, RAND-12, dynamic posturography, video-based head impulse test, bithermal caloric tests, ocular and cervical vestibular evoked myogenic potentials.

Follow-up data after 1 year are the same patient-reported outcomes as at baseline.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients living i Norway referred to Haukeland University Hospital due to newly diagnosed, untreated vestibular schwannoma

排除标准

  • Inability to undergo test protocol due to physical or language barriers

结局指标

主要结局

Dizziness Handicap Inventory (DHI)

时间窗: Baseline and 1-year follow-up

25-item symptom score 0 - 100 points on dizziness handicap severity

次要结局

  • Vertigo Symptom Scale Short Form(Baseline and 1-year follow-up)
  • Haukeland Dizziness Questionnaire (HDQ-10)(Baseline and 1-year follow-up)
  • Hospital Anxiety and Depression Scale (HADS)(Baseline and 1-year follow-up)
  • RAND-12(Baseline and 1-year follow-up)
  • Vertigo Visual Analog Scale(Baseline and 1-year follow-up)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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