The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
Clinical Research Center- Hopital Cardiologique
Lyon, France
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)
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