Effects of Treated and Untreated Allergic Rhinitis on Mood, Cognitive Functions and Actual Driving Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Standard Deviation of Lateral Position (SDLP) in highway driving
研究概览
简要总结
This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory functions. Our group has previously shown that patients suffering from AR symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. Car driving is a typical behavior that is susceptible for changes in sustained attention and might therefore become worse under conditions when patients suffer from AR symptoms. We will compare the driving performance of untreated, symptomatic AR patients with the performance of symptomatic patients that have been treated with either a systemic AR medication (a pill) or a topical medication (nasal spray)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers known with Seasonal Allergic Rhinitis
- •Experienced drivers holding a license
- •21- 45 years of age
排除标准
- •Asthma or other chronic illness
- •current psychoactive medication
- •History of drug abuse
研究组 & 干预措施
Pollen provocation with systemic treatment
Subjects are treated with Cetirizine 10 mg after a nasal challenge with a pollen solution
干预措施: cetirizine 10 mg (Drug)
Pollen provocation with topical treatment
treatment with 25ug fluticasone furoate after a nasal pollen challenge
干预措施: fluticasone furoate (Drug)
placebo treatment after pollen challenge
Placebo treatment after a nasal challenge with pollen solution
干预措施: placebo (Drug)
结局指标
主要结局
Standard Deviation of Lateral Position (SDLP) in highway driving
时间窗: 2:00 - 3:00 hrs post dosing
Standard Deviation of Lateral Position (SDLP) is the amount of "weaving" that occurs when a person is driving in a straight line on the highway and instructed to maintain a steady speed and position within the lane he/she is driving
次要结局
- Word Learning Test (WLT-15) verbal memory score(2:30 hrs post dosing)
研究者
Vuurman
DR Eric Vuurman
Maastricht University Medical Center