Evaluation of a Food Supplement on Sleep Quality (Cyclamax)

This study has been completed.
Sponsor:
Information provided by:
Persee Medica
ClinicalTrials.gov Identifier:
NCT00484497
First received: June 1, 2007
Last updated: June 8, 2007
Last verified: June 2007

June 1, 2007
June 8, 2007
September 2006
Not Provided
Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment
Same as current
Complete list of historical versions of study NCT00484497 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
 
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Insomnia
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
Not Provided
Not Provided

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
Both
25 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00484497
DGS2006/0492
No
Not Provided
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