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Extrait
Background and study aims? Studies have repeatedly shown that modafinil, a drug that promotes alertness, is capable of reversing some of the effects of sleep deprivation. This study aim to assess the impact of modafinil on the thinking skills and hand-eye coordination of a small group of sleep deprived doctors. Who can take part? Male training grade doctors working within or affiliated to Imperial College Healthcare NHS Trust. Participants must be healthy and medication free. Specifically, individuals with a history of neurological illness, heart problems, breathing difficulties, substance misuse or psychiatric illness will not be eligible to take part. What does the study involve? All participants will undergo a period of skills training following which they will attend the study centre for one night of supervised sleep deprivation. Participants will be randomly allocated to receive either modafinil or placebo at 3am and will undergo a series of laboratory based tests of thinking and hand-eye coordination between 6am and approximately 8am. Doctors will be advised not to return to their clinical work for 48hrs following conclusion of the study. What are the possible benefits and risks of taking part? Participants can expect to learn basic technical skills relevant to surgical training. There are no other benefits to the participant form taking part in the study. Possible side effects of modafinil include: neurological side effects such as headache and dizziness, cardiovascular side effects such as fast heart beat and palpitations, respiratory side effects such as cough and wheeze and gastrointestinal side effects such as dry mouth and bowel disturbance. A more detailed description of the drug and list of side effects is available at patient.co.uk: http://www.patient.co.uk/medicine/Modafinil.htm . Where is the study run from? The study will be run from Imperial College London, Department of Surgery and Cancer, St Marys Hospital Campus. When is the study starting and how long is it expected to run for? August 2009 to March 2010 Who is funding the study? Imperial College London, Department of Surgery and Cancer. Who is the main contact? Dr Colin Sugden (Academic Clinical Lecturer) [email protected]
Critère d'inclusion
- Neuropsychopharmacology, sleep deprivation, medical simulation