Evaluation of a Food Supplement on Sleep Quality

Insomnia Clinical Trial

— Cyclamax  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484497
• Other study ID #: DGS2006/0492
• Status: Completed
• Phase: N/A
• First received: June 1, 2007
• Last updated: June 8, 2007
• Start date: September 2006

Study information

• Verified date: June 2007
• Source: Persee Medica
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• cyclamax

Locations

Country	Name	City	State
France	Clinical Research Center- Hopital Cardiologique	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Persee Medica

Country where clinical trial is conducted

France, 

Outcome

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