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临床试验/EUCTR2007-002154-28-NL
EUCTR2007-002154-28-NL进行中(未招募)1 期

Effects of insomnia and chronic use of hypnotics on driving performance - Insomnia, Hypnotics and Driving

Maastricht University0 个研究点目标入组 75 人开始时间: 2007年6月13日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
75

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Aged 55 years or older
  • 2. Possession of a valid driving license for 3 years or more (for >70 years: Possession of Declaration of Appropriateness’ (in Dutch: Verklaring van Geschiktheid))
  • 3. Average driving experience of at least 3000 km per year over the last three years
  • 4. Mentally and physically fit to drive
  • 5. Good health, in the opinion of the medical supervisor, on the basis of a pre-study physical examination, medical history, vital signs, electrocardiogram, and the results of blood biochemistry, haematology, and serology tests, and urinalysis
  • 6. For patients: complaints of insomnia
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. History of drug or alcohol abuse
  • 2. Chronic use of medication that affects driving performance (such as anti-epileptics, anti-psychotics, anti-depressants, anti-parkinsonian medication), except hypnotics
  • 3. Drinking more than 6 cups of coffee per day
  • 4. Drinking more than 21 glasses of alcohol per week
  • 5. Smoking more than 10 cigarettes per day
  • 6. BMI over 30 kg/m²
  • 7. For patients: Sleep-Related Breathing Disorders; Circadian Rhythm Sleep Disorders; Sleep-Related Movement Disorders

研究者

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