A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 主要终点
- Simulated driving variables
研究概览
简要总结
This is a double-blind, parallel design study in elderly primary insomnia patients and demographically matched controls. The objectives if this study are primarily: 1. To determine if functional deficits in simulated driving performance can be demonstrated in primary insomnia patients, and detected in healthy volunteers, impaired by alcohol; and secondarily: 2. To compare simulated driving performance deficits in elderly primary insomnia patients to those in healthy elderly volunteers impaired by alcohol, for at least one of the following driving endpoints: standard deviation of lane position (SDLP), standard deviation of speed (speed deviation), lane excursions, and a driving composite score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Primary insomnia patients and healthy subjects
Elderly participants, including primary insomnia patients and healthy subjects
干预措施: Placebo/ethanol (blinded) (Other)
结局指标
主要结局
Simulated driving variables
时间窗: Evaluated on, up to, 3 different days, with 2 driving sessions of ~65 minutes each day.
Simulated driving variables which may include (standard deviation of lane position (SDLP), speed deviation, lane excursions, or a composite score of several driving variables).
次要结局
未报告次要终点
