Residual effects of zopiclone 7.5 mg on cognition and driving performance in insomnia patients chronically using hypnotics - Insomniacs driving after use of zopiclone 7.5 mg

Maastricht University0 个研究点目标入组 48 人开始时间: 2008年6月23日最近更新: 2024年1月8日

试验速览

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•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

•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

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