Healthy, Sleep Quality
Conditions
Keywords
sleep-EEG, sleep architecture, sleep duration, sleep continuity, REM-sleep, vigilance, well-being, Healthy volunteers
Brief summary
To demonstrate the influence of a herbal preparation containing hypericum, passionflower, and valerian on sleep structure, improvement of attention, and well-being in comparison to placebo.
Detailed description
To demonstrate the influence of the herbal combination preparation Neurapas® balance on the objective sleep structure in comparison with placebo. A further aim was to investigate whether treatment with Neurapas® balance versus placebo brings about an improvement in attention and well-being and whether these changes are related to the improvement in the sleep structure. 1. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in continuity of sleep? 2. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in sleep architecture, especially an increase in deep sleep? 3. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning attentional performance? 4. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning well-being?
Interventions
DRUGNeurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))
3 x 2 tablets / day over 3 days
3 x 2 tablets / day over 3 days
Sponsors
Pascoe Pharmazeutische Praeparate GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male volunteers aged between 18 and 55 years * Normal sleeping times (at least 6 hours a night), going to sleep between 22.00 and 1.00 hours, getting up between 6.00 and 9.00 hours * Written informed consent * The volunteer is willing and able to cooperate fully * The volunteer agrees not to drink any alcohol for the duration of the study
Exclusion criteria
* Participation in another study in the last 30 days or participation in this study at an earlier date * Lack of verbal or intellectual ability to communicate adequately and to understand the information to volunteers * Legal incompetence * Smoker * Shift worker * Transatlantic flight in the last 4 weeks * Taking psychotropic drugs within the last 4 weeks * Taking medicines that influence the EEG within the last 4 weeks * Diseases that influence the sleep EEG * History of known medication / drug / alcohol misuse according to ICD-10 coding F10 - F19 * Known intolerance/hypersensitivity/allergy to St. John's wort, valerian or passionflower * Taking inadmissible concomitant medication (anxiolytic, neuroleptic or hypnotic drugs, cyclosporin, sedative, sleep-promoting or mood-enhancing medicines, antidepressants other than the trial medication, coumarin-type anticoagulants, oral contraceptives, tranquillisers, homeopathic remedies, digoxin, theophylline, indinavir, nortriptyline, amitriptyline) * Known light-sensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture) | Day 3 + 14 |
Secondary
| Measure | Time frame |
|---|---|
| Alertness and vigilance test (TAP) | Day 4 + 15 |
| Trail-Making Test (TMT) | Day 4 + 15 |
| Questionnaire on physical symptoms of subjective well-Being(MKSL, Janke) | Day 4 +15 |
| Attention Stress Test d2 (Brickenkamp) | Day 4 + 15 |
| ZERSSEN Scale of evaluation of subjective well-being (Bf-S) | Day 4 + 15 |
| Sleep Questionnaire(SF) | Day 4 + 15 |
| Questionnaire on psychological aspects of well-being(BSKE, Janke) | Day 4 + 15 |
Countries
Germany
Outcome results
None listed