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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 20, 2014