Study into the effects of sleep deprivation on driving, cognitive ability and pain perceptio
- Conditions
- Sleep disorders
- Registration Number
- NL-OMON24188
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
•Healthy subjects, aged 23 to 35 years, inclusive; healthy is defined as no clinically relevant abnormalities identified by a detailed medical and surgical history and a complete physical examination including vital signs. For part A and B: males only, for part C: females only.
•Body mass index (BMI) between 18 and 32 kg/m2 inclusive.
•Subjects are active and experienced drivers (applicable for part A only):
oIn possession of a driver’s license, minimum driving experience of 5 years or more.
oMinimal car driving mileage of 3000 km per year during the past three years.
•Able to participate and willing to give written informed consent and to comply with the study restrictions.
- History or symptoms of any significant disease including (but not limited to), neurological,
psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic or renal disorder.
- Positive test for drugs of abuse at screening or during the study. Positive tests at screening may be repeated.
- History of and presence of sleep disturbances/disorders.
- Change in time zones 7 days prior to the study periods.
- Smoker of more than 10 cigarettes per day prior to screening or who use tobacco products equivalent to more than 10 cigarettes per day.
- Consume, on average, > 8 units/day of (methyl)-xanthines (e.g. coffee, tea, cola, chocolate) and not able to refrain from use during each stay at the CHDR clinic.
- Presence of Simulator Sickness Syndrome (applicable for part A only).
- Subjects indicating pain tests intolerable at screening or achieving tolerance at >80% of maximum input intensity for any pain test for cold, pressure and electrical tests (applicable for part B and C only).
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Dark skin (Fitzpatrick skin type V - VI), wide-spread acne, tattoos or scarring on the volar forearms (applicable for part B and C only).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method