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Evaluation of a Food Supplement on Sleep Quality (Cyclamax)

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cyclamax
Sponsored by
Persee Medica
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Sleep quality, food supplement, randomized controlled trial, actigraphy, Leeds, Volunteers presenting moderate primary insomnia

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Center- Hopital Cardiologique

Outcomes

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)

Full Information

First Posted
June 1, 2007
Last Updated
June 8, 2007
Sponsor
Persee Medica
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1. Study Identification

Unique Protocol Identification Number
NCT00484497
Brief Title
Evaluation of a Food Supplement on Sleep Quality
Acronym
Cyclamax
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Persee Medica

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Sleep quality, food supplement, randomized controlled trial, actigraphy, Leeds, Volunteers presenting moderate primary insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclamax
Primary Outcome Measure Information:
Title
Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment
Secondary Outcome Measure Information:
Title
Sleep quality assessed by the Leed Sleep Evaluation - Questionnaire, measured 15 days after treatment withdrawal
Title
Sleep quality assessed by a Sleep diary completed each day during all the study period by the participants
Title
Sleep efficiency measured by ambulatory actigraphy (2 period)
Title
Evolution of melatonin/6sulfatoxymelatonin ratio (before and after treatment)
Title
Clinical General Impression of the clinician, before and after treatment.
Title
Safety of the treatment (adverse event reporting)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Cornu, MD
Organizational Affiliation
Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center- Hopital Cardiologique
City
Lyon
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20569455
Citation
Cornu C, Remontet L, Noel-Baron F, Nicolas A, Feugier-Favier N, Roy P, Claustrat B, Saadatian-Elahi M, Kassai 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.
Results Reference
derived

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Evaluation of a Food Supplement on Sleep Quality

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