NCT05834452进行中（未招募）不适用
Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair: A Randomized Controlled Trial Comparing Epley and 360° Maneuvers.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
- 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 Epley maneuver and 360 maneuver in a mechanical rotational chair (TRV chair) in patient with posterior benign paroxysmal positional vertigo (BPPV).
详细描述
Open-label, randomized controlled trial comparing the Epley maneuver with the 360 maneuver using the TRV chair in both scenarios. Patients diagnosed with posterior BPPV will be randomized to receive treatment with either the Epley maneuver or the 360 maneuver.
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
- •Age above 18 years
- •Confirmed unilateral p-BPPV (canalithiasis and cupulolithiasis)
- •Understand written and spoken Danish
排除标准
- •Pregnancy
- •Weight ≥ 150 kg and or Height ≥ 2m
- •Not possible to attend follow-up visits
- •Insufficient cooperation during diagnostic testing or treatment in the mechanical rotational chair
- •Have received treatment for BPPV in a mechanical rotational chair within the last 6 months
- •Sedative antihistamines are taken within the past 7 days
- •Comorbidities: Heart failure (EF<40), known cerebral aneurysm, cerebrovascular events (<3 months), and dissection disease
- •Spontaneous or gaze evoked nystagmus.
结局指标
主要结局
Number of treatments
时间窗: 2 year
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Treatment success after first treatment
时间窗: 2 year
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
次要结局
- Adverse events(2 year)
- Dizziness Handicap Inventory (DHI) Questionnaire(2 year)
- Recurrence rate(2 year)
研究者
Malene Hentze Hansen
medical doctor
Aalborg University Hospital
研究点 (2)
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