Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep

Study Overview
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Brief Summary
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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
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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. 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? 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? 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? 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?

Official Title
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Phase I, Placebo-controlled, Double-blind, Randomised, Single-centre Study of Single Cross-over Design to Investigate the Effects of the Herbal Preparation Neurapas® Balance Compared With Placebo on Sleep EEG, Mental Performance and Well-being

Conditions
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Healthy, Sleep Quality

Intervention / Treatment
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* Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))
* Drug: film-coated sugar-pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>Neurapas balance, film-coated tablets | Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))<br>* 3 x 2 tablets / day over 3 days<br>* Other names: Neurapas balance, film-coated tablet over 3 days;|
| Placebo Comparator: Placebo<br>Film-coated sugar-pill | Drug: film-coated sugar-pill<br>* 3 x 2 tablets / day over 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture) |  | Day 3 + 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention Stress Test d2 (Brickenkamp) |  | Day 4 + 15 | 
| 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 | 
| Questionnaire on psychological aspects of well-being(BSKE, Janke) |  | Day 4 + 15 | 
| ZERSSEN Scale of evaluation of subjective well-being (Bf-S) |  | Day 4 + 15 | 
| Sleep Questionnaire(SF) |  | Day 4 + 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep-EEG, sleep architecture, sleep duration, sleep continuity, REM-sleep, vigilance, well-being, Healthy volunteers