Evaluation of a Food Supplement on Sleep Quality

A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient

The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.

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