Normobaric Oxygen (NBO) Therapy in Acute Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
研究概览
简要总结
This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.
详细描述
A total of 40 adult subjects will be enrolled, male and female. Subjects will be consented to inhale either Normobaric Oxygen (NBO) or Room air for 30 minutes at the start of their migraine attacks. Outcomes will be assessed during and after gas treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult subjects with frequent migraine (at least 1 attack per month)
排除标准
- •Secondary (non-migraine) headache
- •Chronic obstructive pulmonary disease
结局指标
主要结局
Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
时间窗: From baseline (0 minutes) to 30 mins
The mean change in VAS pain scores from 0 minutes to 30 minutes was selected as the primary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
次要结局
- Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)(Baseline (0 minutes) to 15 minutes)
- Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)(Baseline (0 minutes) to 60 minutes)
- Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)(60 minutes)
- Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)(60 minutes)
- Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)(60 minutes)
- Final Nausea Score 0-1 on the Visual Analog Scale (VAS)(60 minutes)
研究者
Aneesh B. Singhal, MD
Associate Professor of Neurology
Massachusetts General Hospital