NCT00223587终止4 期
Study to Investigate the Effects of Seasonal Allergic Rhinitis on Over-the-Road Driving Performance and Memory Functioning
Utrecht Institute for Pharmaceutical Sciences2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2004年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Driving test: Standard Deviation of Lateral Position (SDLP, cm); i.e. the weaving of the car [after 1 week of treatment discontinuation]
研究概览
简要总结
On-the-road driving performance of untreated seasonal allergic rhinitis patients during the allergic season (exposed) is compared to driving performance outside the allergic season (in winter, not-exposed).
详细描述
This study was set-up to examine whether untreated seasonal allergic rhinitis has an effect on driving ability. In addition to the driving tests, patients perform a memory test in the laboratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatients with seasonal allergic rhinitis
- •a valid driver's licence
- •written informed consent
- •a T5SS score >8 during the allergic season and <3 in winter
排除标准
- •use of medication or medical conditions that are known to affect driving ability
- •associated ENT disease or asthma
结局指标
主要结局
Driving test: Standard Deviation of Lateral Position (SDLP, cm); i.e. the weaving of the car [after 1 week of treatment discontinuation]
时间窗: allergic season and winter
次要结局
- Other driving test parameters: standard deviation of speed, mean speed, meal lateral position [after 1 week of treatment discontinuation](allergic season and winter)
- Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation](allergic season and winter)
研究者
研究点 (2)
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