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Evaluation of a Food Supplement on Sleep Quality (Cyclamax)

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ClinicalTrials.gov Identifier: NCT00484497
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : June 11, 2007
Sponsor:
Information provided by:
Persee Medica

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

Condition or disease Intervention/treatment Phase
Insomnia Drug: cyclamax Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient
Study Start Date : September 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment

Secondary Outcome Measures :
  1. Sleep quality assessed by the Leed Sleep Evaluation - Questionnaire, measured 15 days after treatment withdrawal
  2. Sleep quality assessed by a Sleep diary completed each day during all the study period by the participants
  3. Sleep efficiency measured by ambulatory actigraphy (2 period)
  4. Evolution of melatonin/6sulfatoxymelatonin ratio (before and after treatment)
  5. Clinical General Impression of the clinician, before and after treatment.
  6. Safety of the treatment (adverse event reporting)


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484497


Locations
France
Clinical Research Center- Hopital Cardiologique
Lyon, France, 69677
Sponsors and Collaborators
Persee Medica
Investigators
Principal Investigator: Catherine Cornu, MD Clinical Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00484497     History of Changes
Other Study ID Numbers: DGS2006/0492
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: June 11, 2007
Last Verified: June 2007

Keywords provided by Persee Medica:
Sleep quality
food supplement
randomized controlled trial
actigraphy
Leeds
Volunteers presenting moderate primary insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders