NCT03472417已完成不适用
Partial Rebreathing in the Treatment of Migraine With Aura
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Headache Intensity Difference at 0 vs 2 hours post-treatment
研究概览
简要总结
A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Migraine with aura
- •Attack frequency of between one and six migraine-with-aura attacks per month over the last six months
- •Adults (18-60 years)
- •Age at onset of migraine < 50 years
- •If taking migraine prophylactic drugs, the dosis must have been stable for > 3 months
- •Must speak and understand Danish
排除标准
- •- Cardiovascular disease, pulmonary disease, metabolic acid/base disorder, cancer, moderate and severe depression, anemia or other blood disease
- •Chronic migraine, i.e. more than 15 headache days per month over the last three months
- •Medication overuse headache
- •More than six migraine-with-aura attacks per month
- •Non-migraine headache on more than six days per month
- •A typical duration between migraine-with-aura attacks of less than 48 hours
研究组 & 干预措施
Active partial rebreathing device
Active Comparator
干预措施: Active partial rebreathing device (Device)
Dummy partial rebreathing device
Sham Comparator
干预措施: Dummy partial rebreathing device (Device)
结局指标
主要结局
Headache Intensity Difference at 0 vs 2 hours post-treatment
时间窗: 2 hours
0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
次要结局
- Nausea Intensity Difference 0 vs 1 hour post-treatment(1 hour)
- Aura symptoms aborted after one use of device(20 minutes)
- Side effects(through study completion (1 to 10 months))
- Adverse events(through study completion (1 to 10 months))
- Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale)(1 hour)
- Pain reduction/relief at 1 hour(1 hour)
- Pain reduction/relief at 2 hours(2 hours)
- Nausea Intensity Difference 0 vs 2 hours post-treatment(2 hours)
- Photo - and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment(1 hour)
- Sustained pain freedom at 24 hours(24 hours)
- Treatment preference vs. patient's normal treatment(24 hours)
- Medicine use in 24 hours after device use(24 hours)
- Functional Disability Difference 0 vs 2 hours post-treatment(2 hours)
- Photo - and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment(2 hours)
- Functional Disability Difference 0 vs 1 hour post-treatment(1 hour)
研究者
研究点 (2)
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