Evaluation of a Food Supplement on Sleep Quality
Not Applicable
Completed
- Conditions
- Insomnia
- Registration Number
- NCT00484497
- Lead Sponsor
- Persee Medica
- Brief Summary
The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
- Healthy volunteer aged between 25 to 65 years
- Patient diagnosed for primary Insomnia (threshold for inclusion: 10 on the ISI scale)
- Healthy volunteer without diurnal sleep (total score for inclusion must be less than 10 on the Epworth scale)
- Patient affiliated to the French Social Security
- Patient who gave written informed consent
Exclusion Criteria
- Secondary insomnia
- History of severe psychiatric disorder, assessed by the MINI test
- Resistance to Hypnotic drugs
- Anxiety, depression, suicide, detected by the Beck Depression Inventory
- Acute Pathology during the precedent three years
- Breast feeding and pregnancy women
- Non compliant volunteer
- Hypersensibility to treatment composant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment
- Secondary Outcome Measures
Name Time Method Sleep efficiency measured by ambulatory actigraphy (2 period) Sleep quality assessed by the Leed Sleep Evaluation - Questionnaire, measured 15 days after treatment withdrawal Sleep quality assessed by a Sleep diary completed each day during all the study period by the participants Evolution of melatonin/6sulfatoxymelatonin ratio (before and after treatment) Clinical General Impression of the clinician, before and after treatment. Safety of the treatment (adverse event reporting)
Trial Locations
- Locations (1)
Clinical Research Center- Hopital Cardiologique
🇫🇷Lyon, France