跳至主要内容
临床试验/NCT03871413
NCT03871413已完成不适用

Can Benign Paroxysmal Positional Vertigo (BPPV) be Treated Faster and More Efficiently by Using a Mechanical Rotational Chair Compared to the Traditional Manual Repositioning Maneuvers?

Aalborg University Hospital2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
2
主要终点
Number of treatments

研究概览

简要总结

Comparison of treatment efficacy of a mechanical rotational chair (TRV-chair) vs. manual repositioning maneuvers in BPPV

详细描述

Open-label, randomized controlled trial comparing manual repositioning maneuvers with a mechanical rotational chair (TRV-chair) in diagnosing and treating BPPV. Patients with suspected BPPV will be randomized to either manual repositioning maneuvers or the TRV-chair.

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

  • Characteristic (for BPPV) positional nystagmus
  • Positive Dix-Hallpike
  • Positive supine roll test
  • Medical history compatible with BPPV

排除标准

  • Treatment in TRV-chair within the last 6 months
  • Exclusion of BPPV diagnosis
  • Lack of treatment cooperation
  • Known cerebral aneurism or cerebral hemorrhage
  • Diagnosed and treated for BPPV within the past month
  • Treatment with sedating anti-histamines within the past 7 days

结局指标

主要结局

Number of treatments

时间窗: 2 years

Number of treatment necessary to achieve resolution of vertigo and nystagmus

Treatment success after first treatment

时间窗: 2 years

Number of subjects achieving resolution of vertigo and nystagmus after one treatment

次要结局

  • Dizziness Handicap Inventory (DHI) questionnaire(2 years)
  • Adverse events(2 years)

研究者

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

Dan Dupont Hougaard

MD, Associate Professor, Principal Investigator

Aalborg University Hospital

研究点 (2)

Loading locations...

相似试验