Study of sleep characteristics and parameters in patients suffering from minors sleep disorders treated by the homeopathic medicinal product Somnidoron®, oral drops, solution. - Somnilog

• Conditions: Minors sleep disorders; MedDRA version: 8.1Level: LLTClassification code 10040984Term: Sleep disorder

• Registration Number: EUCTR2006-005103-33-FR
• Lead Sponsor: aboratoires WELEDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified