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Clinical Trials/NCT00484497
NCT00484497CompletedNot Applicable

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

Persee Medica2 sites in 1 country105 target enrollmentStarted: September 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
105
Locations
2
Primary Endpoint
Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
25 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment

Secondary Outcomes

  • 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)

Investigators

Sponsor
Persee Medica
Sponsor Class
Industry

Study Sites (2)

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