Minors sleep disorders MedDRA version: 8.1 Level: LLT Classification code 10040984 Term: Sleep disorder
Conditions
Interventions
Trade Name: Somnidoron, oral drops, solution (bottle of 30ml)
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Coffea tosta 20 DH
Concentration unit: ml millilitre(s)
Concentration type
Sponsors
Laboratoires WELEDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Anyone consulting a physician taking part in the study for a minor sleep disorder: - Adult aged between 18 and 70 years - With light to moderate intensity minor sleep disorder, confirmed by Spiegel questionnaire (score = 15). - Men or women using efficient contraceptive methods or post-menopausal women 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: - Secondary insomnia - Serious organic affection - Psychosis being able to appear by sleep disorders - Contra indication (Summary of product Characteristics) - Patient treated for sleep disorders - Patient trated by corticoid or beta-blocker medication - Worker having a night shift - Deficient knowledge or understanding of french language to complete correctly the self assessment questionnaire. - Participation in another clinical trial - Pregnant woman or nursing mother
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the sleep latency of patients with minor sleep disorders and its evolution with homeopathic medicinal product, evaluated by actimetry and by sleep diary.;Secondary Objective: 1) To describe the other sleep characteristics and parameters of patients, their evolution with homeopathic medication (quality, total sleep time, total time of awakening intra sleep, dreams, quality of awakening) collected from data of Spiegel self assessment questionnaire, sleep diary and actimeter. 2) To describe the relationship between self assessment questionnaire data, sleep diary data and data collected with the actimeter on sleep latency and the others characteristics of sleep. 3) To describe and analyze the treatment response level, treatment tolerance, and the effect of the treatment on sleep quality (Leeds questionnaire) ;Primary end point(s): The primary end point of the study is the variation of the sleep latency, between V1 (baseline) and V2 (end of treatment) evaluated by actimeter (automatic recording) and sleep diary (given by patient). | — |
Countries
France
Outcome results
None listed