Insomnia
Conditions
Keywords
Sleep quality, food supplement, randomized controlled trial, actigraphy, Leeds, Volunteers presenting moderate primary insomnia
Brief summary
The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.
Interventions
DRUGcyclamax
Sponsors
Persee Medica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
| Sleep quality assessed by the Leed Sleep Evaluation - Questionnaire, measured 15 days after treatment withdrawal | — |
| Clinical General Impression of the clinician, before and after treatment. | — |
| Safety of the treatment (adverse event reporting) | — |
| Evolution of melatonin/6sulfatoxymelatonin ratio (before and after treatment) | — |
Countries
France
Outcome results
None listed