Acute Unilateral Vestibulopathy and Corticosteroid Treatment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Caloric function
研究概览
简要总结
Randomized placebo controlled trial on patients suffering from acute unilateral vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days).
Vestibular function as well as subjective symptoms will be estimated in the acute stage and regularly up to one year after the debut.
详细描述
Randomized controlled trial in 3 arms to see if a short or a even shorter period of steroid treatment on patients diagnosed with vestibular neuritis can be as effective as the only comparable study thus far (Strupp et al, NEJM 22, 351(4) 354-61). If a shorter treatment with a lower dose has the same outcome, then more patients might be eligible for the treatment as many are excluded due to risk for adverse effects.
Corticosteroid treatment in acute unilateral vestibulopathy has recently been the subject for a Cochrane review with the conclusion of insufficient evidence for treatment effect and recommend studies with subjective symptom based evaluation together with functional testing.
Patients with acute unilateral vestibulopathy diagnosed within 48hrs after debut. The patients (after acceptance) will be randomized into either of 3 arms and will receive placebo/short treatment (3days)/standard treatment (in Sweden 11 days).
Patients will record subjective symptoms according to Liknert scale during the acute stage and fill out enquiries after 3 and 12 months.
Vestibular function will be assessed with caloric irrigation and video-Head-Impulse-Test (vHIT) as soon as possible after the debut and again after 1, 3 and 12 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definite unilateral vestibulopathy
- •no pathological HINTS (examination criteria in acute vestibular syndrome)
- •capable of making their own decisions
排除标准
- •tinnitus or hearing loss with same debut as vertigo
- •history of bleeding peptic ulcer
- •pregnancy or non-acceptance to use anticonception measures during 13 days after debut
- •high blood pressure >180 systolic, 105, diastolic
- •ketoacidosis with a Base Excess >=2
- •psychic disorder (not including mild depression)
- •serious infection (neutropenia, tuberculosis)
- •chronic otitis
- •history of vertiginous disease; Ménière, Vertiginous migraine, atypical BPPV
研究组 & 干预措施
Placebo
Day 1: Intravenous sodium-chloride 2ml Day 2-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo
干预措施: Placebo (Drug)
Short treatment
Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-3: 10 tablets prednisolone 5 mg Day 4-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo
干预措施: Betamethasone (Drug)
Short treatment
Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-3: 10 tablets prednisolone 5 mg Day 4-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo
干预措施: Prednisolone (Drug)
Standard treatment
Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-6: 10 tablets prednisolone 5 mg Day 7: 8 tablets prednisolone 5 mg Day 8: 6 tablets prednisolone 5 mg Day 9: 4 tablets prednisolone 5 mg Day 10: 2 tablets prednisolone 5 mg Day 11: 1 tablet prednisolone 5 mg
干预措施: Betamethasone (Drug)
Standard treatment
Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-6: 10 tablets prednisolone 5 mg Day 7: 8 tablets prednisolone 5 mg Day 8: 6 tablets prednisolone 5 mg Day 9: 4 tablets prednisolone 5 mg Day 10: 2 tablets prednisolone 5 mg Day 11: 1 tablet prednisolone 5 mg
干预措施: Prednisolone (Drug)
结局指标
主要结局
Caloric function
时间窗: 1 year
Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function
次要结局
- Saliva-Cortisol(At debut and up to 1 week)
- Hospital stay(From debut up to 10 days)
- Daily living(debut up to 1 year)
- Vertigo Diary(Daily from debut and until no subjective vertigo is experienced, longest 4 weeks)
- Sleep Diary(Daily from debut and 14 days onwards (2 days after last treatment))
- VSS-enquiry(3 and 12 months after debut)
- VHQ-enquiry(3 and 12 months after debut)
- vHIT(1 year)
- Subjective visual vertical/horizontal(1 year)
- Covert saccades(1 year)
- HADS-enquiry(3 and 12 months after debut)
- Adverse Events(From debut to 1 year after)
- DHI-enquiry(3 and 12 months after debut)
- Stress hormones(At debut and 1 year)
- Sick-leave(debut up to 1 year)