Efficacy of a New Type of Mechanical Rotational Chair (ROTUNDUM) in Treating BPPV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Treatment success after first treatment
研究概览
简要总结
A study to establish the efficacy of a new type of mechanical rotational chair in treating BPPV. In addition, comparison of three types of treatment maneuvers using the mechanical rotational chair.
详细描述
Open-label, randomized controlled trial comparing three different treatment maneuvers in a mechanical rotational chair (ROTUNDUM-chair) in treating BPPV. Patients diagnosed with BPPV will be randomized to one of three maneuvers in the ROTUNDUM-chair:
- Epley's maneuver
- Semont maneuver
- 360 degree vertical rotation
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
- 否
入选标准
- •Characteristic (for BPPV) positional nystagmus
- •Positive Dix-Hallpike Test
- •Medical history compatible with BPPV
排除标准
- •Treatment in a mechanical rotational chair within the last 6 months
- •Exclusion of BPPV diagnosis
- •Lack of treatment cooperation
- •Known cerebral aneurism or cerebral hemorrhage
- •Treated for BPPV within the past month
结局指标
主要结局
Treatment success after first treatment
时间窗: 2 years
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Number of treatments
时间窗: 2 years
Number of treatments necessary to achieve resolution of vertigo and nystagmus
次要结局
- Dizziness Handicap Inventory (DHI) questionnaire(2 years)
- Value of liberatory nystagmus(2 years)
- Adverse events(2 years)
研究者
Dan Dupont Hougaard
MD, Associate Professor, Principal Investigator
Aalborg University Hospital