Evaluation of a Food Supplement on Sleep Quality

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Persee Medica

Criteria

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