Evaluation of a Food Supplement on Sleep Quality (Cyclamax)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484497
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : June 11, 2007
Information provided by:
Persee Medica

June 1, 2007
June 11, 2007
June 11, 2007
September 2006
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Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment
Same as current
No Changes Posted
  • 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
  • Sleep efficiency measured by ambulatory actigraphy (2 period)
  • 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)
Same as current
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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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Drug: cyclamax
Not Provided
Cornu C, Remontet L, Noel-Baron F, Nicolas A, Feugier-Favier N, Roy P, Claustrat B, Saadatian-Elahi M, Kassaï B. A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial. BMC Complement Altern Med. 2010 Jun 22;10:29. doi: 10.1186/1472-6882-10-29.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
Not Provided
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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
Sexes Eligible for Study: All
25 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Persee Medica
Not Provided
Principal Investigator: Catherine Cornu, MD Clinical Research Center
Persee Medica
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP