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.
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?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
3 x 2 tablets / day over 3 days
3 x 2 tablets / day over 3 days
Phillipps University, Clinic for Psychiatry and Psychotherapy
Marburg, Hesse, Germany
Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)
Time frame: Day 3 + 14
Attention Stress Test d2 (Brickenkamp)
Time frame: Day 4 + 15
Alertness and vigilance test (TAP)
Time frame: Day 4 + 15
Trail-Making Test (TMT)
Time frame: Day 4 + 15
Questionnaire on physical symptoms of subjective well-Being(MKSL, Janke)
Time frame: Day 4 +15
Questionnaire on psychological aspects of well-being(BSKE, Janke)
Time frame: Day 4 + 15
ZERSSEN Scale of evaluation of subjective well-being (Bf-S)
Time frame: Day 4 + 15
Sleep Questionnaire(SF)
Time frame: Day 4 + 15
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