insomnia (insomnie) use of hypnotics (slaapmiddelengebruik)
Conditions
Interventions
Subjects receive a single oral dose of zopiclone 7.5 mg or placebo. Balancing of treatments will be accomplished by randomly assigning subjects to one of two treatment sequences (placebo – zopiclone o
Sponsors
Maastricht University
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Aged 55 years or older 3. Possession of a valid driving license for 3 years or more (for >70 years: Possession of “Declaration of Appropriateness’ (in Dutch: Verklaring van Geschiktheid)) 4. Average driving experience of at least 3000 km per year over the last three years 5. Mentally and physically fit to drive 6. Signed Informed Consent Form 7. 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 8. For patients: complaints of insomnia
Exclusion criteria
Exclusion criteria: 1. History of drug or alcohol abuse 2. Presence of significant medical (e.g. cancer), neurological (e.g. dementia, epilepsy, Parkinson), or psychiatric disorders (e.g. psychosis, major depression) 3. Chronic use of medication that affects driving performance (such as anti-epileptics, anti-psychotics, anti-depressants, anti-parkinsonian medication), except hypnotics 4. Drinking more than 6 cups of coffee per day 5. Drinking more than 21 glasses of alcohol per week 6. Smoking more than 10 cigarettes per day 7. BMI over 30 kg/m² 8. For patients: Sleep-Related Breathing Disorders; Circadian Rhythm Sleep Disorders; Sleep-Related Movement Disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Highway driving test: Standard Deviation of Speed (SDSP in km/h) - Car following test: Time to Speed Adaptation (TSA, in ms), brake reaction time (BRT, in ms) and Standard Deviation of Headway (SDH). Cognitive and psychomotor tests: • 15-Word Learning Test (Immediate and Delayed Recall Scores, Speed and accuracy of Recognition); • Critical Tracking Task (Average lambda [in rad/s]); • Divided Attention Task (Tracking Error [in mm], Target Detection Time [in ms]; • Stop Signal Task (Go Reaction Time [in ms], Stop Signal Reaction Time [in ms]); • Psychomotor Vigilance Task (mean Reaction Time [in ms]; percentage of Lapses [in %]; • Digit Span Backward and Forward (Maximum Forward and Backward Score). • Subjective evaluations: Subjective alertness assessed by Visual Analogue Scales | — |
Contacts
Public ContactTim R.M. Leufkens
Maastricht University Fac. of Psychology Dept. of Neuropsychology & Psychopharmacology PO Box 616
Outcome results
None listed