跳至主要内容
临床试验/NCT01209728
NCT01209728已完成1 期

A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs

Merck Sharp & Dohme LLC0 个研究点目标入组 76 人开始时间: 2010年10月1日最近更新:
适应症
干预措施

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

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

Experimental

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

研究者

申办方类型
Industry
责任方
Sponsor

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