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

Persee Medica1 site in 1 country105 target enrollmentSeptember 2006

ConditionsInsomnia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Insomnia
Sponsor: Persee Medica
Enrollment: 105
Locations: 1
Primary Endpoint: Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment
Status: Completed
Last Updated: 18 years ago

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

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Persee Medica

•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

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

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)