Intracranial Pressure in Experimental Models of Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Optic Nerve Sheath Diameter by Ultrasonography
研究概览
简要总结
The purpose of this study is to determine whether increased pressure in the head is elevated in people who suffer from High Altitude Headache. We hypothesise that head pressure will be elevated in people with High Altitude Headache.
详细描述
High Altitude Headache is the primary symptom of Acute Mountain Sickness. However, at present the reason why some individuals suffer from High Altitude Headache and others do not remains unknown. It is widely believed that elevated pressure within the brain leads to stretching of pain sensitive fibres and thus headache. However, evidence of raised intracranial pressure during High Altitude Headache is currently unavailable. Therefore, this study aims to examine a proxy measure of intracranial pressure (Optic Nerve Sheath Diameter) in persons visiting High Altitude, half of whom have been given the drug acetazolamide that is known to reduce headache symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Member of the Italian High Altitude Research Expeditions
排除标准
- •Are under the age of 18years;
- •sulfonamide allergy
- •Liver or kidney disfunction
- •Have any other uncontrolled medical condition
- •Or are unable to give consent.
研究组 & 干预措施
Acetazolamide
Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
干预措施: Acetazolamide (Drug)
Placebo
Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
干预措施: Lactose monohydrate (Drug)
结局指标
主要结局
Change in Optic Nerve Sheath Diameter by Ultrasonography
时间窗: Optic Nerve Sheath Diameter: baseline, 24 hours.
Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Optic nerve sheath diameter obtained by ultrasonography of the eye. Increased optic nerve sheath diameter suggests greater intra cranial pressure.
次要结局
- Change in Fluid Balance(Fluid Balance: baseline, 24 hours.)
- Change in High Altitude Headache by Visual Analogue Scale(High Altitude Headache: baseline, 24 hours.)
- Change in Blood Oxygen Saturation(Blood Oxygen Saturation: baseline, 24 hours.)
- Change in Optic Nerve Sheath Diameter(Optic Nerve Sheath Diameter: baseline, 36 hours.)