Trial | NCT00484497  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cyclamax ...

  • Study Participants

    105
The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.
Study Started
Sep 30
2006
Last Update
Jun 11
2007
Estimate

Drug cyclamax

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
No Results Posted