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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
History of Changes
  Purpose

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


Condition Intervention
Insomnia
 Drug: cyclamax

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Persee Medica:

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

Secondary Outcome Measures:
  • 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)

Enrollment: 105
Study Start Date: September 2006
  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Persee Medica

Additional 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
Study First Received: June 1, 2007
Last Updated: June 8, 2007
Health Authority: France: Ministry of Health

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 Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on June 13, 2013