The acute effects of oxazepam on actual driving performance and cognitive functions
- Conditions
- cognitief functionerennot applicable
- Registration Number
- NL-OMON41122
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 27
- healthy males or females, in the opinion of the medical supervisor, based on a pre-study physical examination, medical history, vital signs, electrocardiogram, and the results of blood chemistry, haematology, and urinalysis
- aged between 23 and 50 years (inclusive)
- BMI between 19 and 29 m2/kg (inclusive)
- possession of a valid driving license for 4 years or more
- driving experience of at least 3000 km per year on average
- good sleepers
- subjects should sign an Informed Consent Form
- history of mental illness
- sleep disorders such as insomnia and narcolepsy
- history of or current drug or alcohol abuse
- current use of psycho-active medication, and inability to stay abstinent during the study
- excessive alcohol use, defined as drinking more than 21 glasses of alcohol per week
- excessive caffeine use, defined as drinking 5 or more cups of coffee per day
- smoking more than 10 cigarettes per day
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the Standard Deviation of Lateral Position (SDLP in<br /><br>cm) in the highway driving test.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters will be accuracy and/or speed in the following tests:<br /><br>* Psychomotor Vigilance Test (PVT)<br /><br>* Critical tracking test (CTT)<br /><br>* Divided Attention Test (DAT)<br /><br>* Useful Field of View (UFOV)<br /><br>* Digit Symbol Substition Test (DSST)<br /><br>* Postural Balance test (PBT)<br /><br>* Vienna Test System Determination Test (DT)<br /><br>* Attention Network Test (ANT)</p><br>