Effects of insomnia and chronic use of hypnotics on driving performance - Insomnia, Hypnotics and Driving
- Conditions
- Primary insomniaMedDRA version: 9.1Level: LLTClassification code 10036701Term: Primary insomnia
- Registration Number
- EUCTR2007-002154-28-NL
- Lead Sponsor
- Maastricht University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to compare over-the-road driving performance of treated and untreated patients complaining of insomnia, with that of healthy controls matched for age, gender and annual mileage.;Secondary Objective: The secondary objective of the study is to compare cognitive and psychomotor performance related to driving of treated and untreated patients complaining of insomnia, with that of healthy controls matched for age, gender and annual mileage.;Primary end point(s): The main study parameter/primary end point is Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test
- Secondary Outcome Measures
Name Time Method