Effects of Modafinil and Caffeine during the circadian trough on vigilance in healthy RNLAF aircrew: a randomized controlled trial

Phase 1

• Conditions: fatigue in healthy aircew; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2017-002288-16-NL
• Lead Sponsor: Center for Man in Aviation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-03
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 36

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified