fatigue in healthy aircew
Conditions
Interventions
Trade Name: Aspendos
Modiodal
Modafinil (generic)
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Sponsors
Center for Man in Aviation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 55 years of age. IV. All subjects need to be in good health, and may not have any chronic diseases. V. Subjects must have an electrocardiographic QTc time within normal limits VI. Body Mass Index must be between 19 and 30 kg/m2 IV.VII. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria are mostly based on possible side effects or interactions of one or both of the medicines. i. Pregnant or nursing women are not eligible, modafinil is possibly teratogenic. There has not been enough research to prove modafinil safe for use during pregnancy. ii. People with known heart, kidney or liver disease or neurological complaints are not eligible 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 disqualifies for the trials; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of modafinil and caffeine on vigilance in low, medium and high caffeine consumers during the circadian trough in order to determine the best pharmacological agent to target fatigue. ;Secondary Objective: Not applicable; Primary end point(s): The main endpoint is the root mean square of tracking error of the VigTrack test. The results will give a very good indication of the vigilance of the test subject. Other endpoint are: Vigilance &Tracking Test (VigTrack): percentage omissions and number of false reactions Psychomotor Vigilance Task (PVT): reaction time, lapses and number of misses. Stanford Sleepiness Scale (SSS): sss-scores Epworth Sleepiness Scale (ESS): ess-scores vital parameters: blood pressure, temperature, and pulse ;Timepoint(s) of evaluation of this end point: Evaluations will be done at -6, 0, +2, +3, +4, +6, +8 hours following each drug administration period. During entry these evaluations will also be done, but only to practice. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Bloodsamples (intravenous) to determine caffeine-and modafinil levels in blood. ;Timepoint(s) of evaluation of this end point: 8 bloodsamples (intravenous) during each testday | — |
Countries
Netherlands
Contacts
Public ContactContact point
Center for Man in Aviation
Outcome results
None listed