vigilance (fatigue)- waakzaamheid (vermoeidheid)
Conditions
Interventions
200 mg Modafinil: Wakefulness promoting agent (psychostimulant)
300 mg Caffeine: Alertness aid.
Sponsors
n.a.
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: I. The potential participant has given informed and written consent and is able to comply with all study assessments scheduled in the protocol. II. All personnel need to be aircrew members of the Royal Netherlands Air Force, irrespective of their position. III. All subjects need to be between 18 and 60 years of age. IV. All subjects need to be in good health, and may not have any chronic diseases. V. All female subjects need to take supplementary contraceptives, if they are using the birth control pill as the contraceptive of choice. VI. Subjects must be able to communicate, participate, and comply with the requirements of the entire study, including completion of all the visits along with the domiciled periods and sleep questionnaires.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Exclusion criteria are mostly based on possible side effects or interactions of one or both of the medicines. i. Pregnant or nursing women, as modafinil is possibly teratogenic. There has not been enough research to prove modafinil is safe for use during pregnancy. A pregnancy test will be performed on every test day. ii. People with known heart, kidney or liver disease or neurological complaints. iii. People who use medication that is being metabolized through CYP3A4/5, CYP2C19 of CYP2C9, since this might alter the plasma levels of the used medication and modafinil. iv. A history of psychiatric illness; this includes sleeping disorders v. One week prior to starting every trial day, all subjects need to be (and remain) in a time zone that is a maximum of 4 time zones away from the CET time zone in which the research center lies. (GMT+1, daylight savings GMT+2). This to exclude jet lags that might confound the test results. vi. Known allergies for caffeine, modafinil or any of its ingredients or metabolites. Women using hormone based birth control ( e.g. oral contraceptives, intra-uterine device) will be very well informed prior to taking part due to the interference between hormones and modafinil. There will be no interference with the working mechanism of modafinil or its efficacy, but there is a known decreased effect of the contraceptive when used simultaneously with modafinil. Women using hormone-based contraceptives can therefore participate if they are willing to use other non-hormone based contraceptives as well. It is therefore not a direct exclusion criterion, but women will be informed concerning the lower efficacy of hormonal contraceptives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vigilance &Tracking Test (VigTrack): -root mean square of tracking error -percentage omissions -reaction time Psychomotor Vigilance Task (PVT): -reaction time (RT) -lapses -misses Stanford Sleepiness scale (SSS) Epworth Sleepiness scale (ESS) | — |
Contacts
Public ContactY.Q. Wingelaar-Jagt
Outcome results
None listed