volunteers with non-organic slight insomnia (DSM IIII R primary insomnia).
Conditions
Interventions
Trade Name: Dormeasan
Product Name: Dormeasan
Product Code: SPC 0015.e03
Pharmaceutical Form: Oral drops*
INN or Proposed INN: Baldrian / Hopfen Extrakt - Tropfen
Current Sponsor code: NCAG 1304
Other
Sponsors
Bioforce GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * both sexes, * age between 30 and 70 years (each inclusive), * only slight sleep disturbance with inconspicuous history and clinical findings, *objective findings - during polysomnographic recording - of sleep disturbances (total sleep time 30min and/or percentage of toatl awaking time >10% realted to total bed time], * negative finding of alcohol at the time of screening-investigation and at the evening of test night, * written informed consent to participate at the study (informed consent). * protection to get pregnant in woman in childbearing ages. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * clinical relevant acute or chronical diseases, * clinical relevant sleep disturbances need to be treated (e.g. sleep apnea, parasomnia), * clinical relevant pathological findings from clinical or laboratoty results, * clinical pathological EEG-findings, * clinical relevant Allergies, * drug or alcohol abuse, * positive finding of alcohol at Screening-investigation, * clinical relevant drugs taken in in the last 3 days before the first test night (visit1), and during active study phase, * clinical relevant drugs to be taken continuously, * body weight 115 kg, * abuse of coffee, tee or tobacco, /smoking within 2 h before arrival at the trial centre and start of the polysomnographic recording (PSG). /coffein 4 h before arrival at the trial centre and start of the PSG. /alcohol 24 h before arrival at the trial centre and start of the PSG. * missing written informed consent, * participation in another clinical study within 60 days before start of the study. * pregnancy or breastfeeding period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Sleep duration (min) Basis: validated sleep depth index SFx (developed by Dimpfel, 1998) in comparison to placebo.;Secondary Objective: A) on the neurophysiological site the parameter extracted from polysomnography (Todorova et al., 1997): A1) sum of times where absolute delta- and theta-power is present over the tested night (quantitative EEG parameter). A2) REM sleep latency, A3) sleep efficiency (related to total time in bed) [%], A4) total time of deep sleep [min], A5) total time of being awake [min], A6) counts of awakening events during the night sleep. B) on the clinical site, subjectively by the volunteer estimated: B1) sleep quality B2) feeling of recovery (GES, Basis SF-A). ;Primary end point(s): One confirmatoric goal parameter (total sleeping time (S-Dauer)) over the total re-corded period of 8 h (10.00 p.m. at evening to 6:00 a.m. at the following morning)*. The validated SFx-Parameter (dependent from time) will be used: S-Dauer =: Integral (from 0 to 480 min*) over time f(SFx(t)) dt. whereby f(SFx(t)) = min (1, (max (0, (80 - SFx(t))/3)). (min = Minimum, max = Maximum). S-Dauer describes the time duration of the sleep*. | — |
Countries
Germany
Outcome results
None listed