Sleep Disorders, Circadian Rhythm
Conditions
Brief summary
The general aim of this study is to assess the effects of Pharmaton® Caplets on mental performance and physical fatigue in nurses and nursing auxiliaries working night shifts
Interventions
DRUGPharmaton® Caplets
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female nurses and nursing auxiliaries working night shift * Age range: 20 to 45 inclusive * BMI range: 18-30 * Negative pregnancy test for females * Subjects must be free of any clinically significant disease or condition that required a physician's care and/or was to interfere with study evaluation and procedures * Clinical laboratory tests within normal limits or, if out of normal range, clinically acceptable to the investigator * Negative urine drug screen for drugs at screening * Subjects must be willing to give informed consent prior to study enrolment and be able to adhere to restrictions and examination schedules
Exclusion criteria
* Any serious disorder that may interfere with his/her participation to the trial and the evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis A, psychic disorder, etc.) and/or treatment with chronic medication * Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation) * Individuals drinking more than 40 g alcohol/day (glass of 12.5 cl of wine 10° = 12 g; glass of 4 cl of aperitif 42° = 17 g; glass of 25 cl of beer 3° = 7.5 g; glass of 25 cl of beer 6° = 15 g); Alcohol and drug abuse according to Diagnostic and Statistic Manual, Version IV (DSM-IV) * Individuals drinking more that 6 cups of coffee or tea/day * Individuals smoking more than 10 cigarettes/day * Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, Intrauterine Device (IUD), sterilization) * Pregnancy and/or lactation * Relevant allergy or known hypersensitivity to the investigational product or its excipients * Individuals taking or having taken recently other vitamins and minerals supplementation * Individuals with a current disorder likely to modify EEG recordings and/or computerized cognitive testing * Individuals having a history of cancer * Participation in another clinical trial within the last 3 months prior to the start of the study and concurrent participation in another clinical trial * Individuals without health insurance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift) | at day 77 |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of spontaneous Electroencephalogram (EEG) and event related potentials | up to day 77 |
| Assessment of Sleep-Electroencephalogram parameters | Day -1, Day 1, Day 77 |
| Evaluation of Quality of life scales | up to day 77 |
| Evaluation of Sleep by Visual Analogue Scale (VAS) | up to day 77 |
| Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram) | up to day 77 |
| Assessment of urinary cortisol levels | Day -1, Day1, Day 77 |
| Number of patients with adverse events | up to 3 months |
| Assessment of tolerability by investigator on a 4-point scale | at day 77 |
| Assessment of tolerability by subject on a 4-point scale | Day 41, Day 77 |
| Assessment of 24-hours holter Electrocardiogram (ECG) | Day -1, Day1, Day 77 |
Outcome results
None listed