The Effects of Nicotine Chewing Gum on Acute Low Blood Pressure in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
The objective of this experiment is:
To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension in PD subjects.
详细描述
Subjects will be asked to sit and rest for 10 minutes. Blood pressure will be taken in this resting position after the 10 minutes.
After all inclusion criteria has been met, subjects will then wear an automated BP cuff and be administered 4mg of nicotine gum (Nicorette™). They will be instructed to use it according to manufacturer's directions and remain chewing the gum for 30 minutes. The subject will remain in a seated position and BP and HR will be recorded every 5 minutes for 30 minutes. After 30 minutes the gum will be removed and subjects will still have HR and BP monitored in the seated position for another hour every 10 minutes. All values will be compared to pretreatment values. After 120 minutes if the subject is non-symptomatic, they can go home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of PD
- •a diastolic BP less than 90 mmHg
- •and/or a systolic BP lower than 100mHg.
排除标准
- •current tobacco users in all forms of tobacco
- •severe dysphasia (difficulty swallowing)
- •previous tobacco users who might be at risk for re-addiction.
结局指标
主要结局
Blood Pressure
时间窗: 90 minutes
次要结局
- Heart Rate(90 Minutes)
研究者
Joanne DiFrancisco-Donoghue
Assistant Professor
New York Institute of Technology