Effect of Lactium on Sleep Disorders in Healthy Volunteers With Persistent Subclinical Insomnia

Exclusion Criteria

• •1. Presenting moderate to severe insomnia defined by an ISI score greater than or equal to 15 in the last month prior to selection
• •2. Presenting other sleep disorders already diagnosed or suspected during the screening visit: impatience (restless legs), parasomnias, hypersomnias, sleep apnea, iatrogenic insomnia
• •3. Subject assessed as "definitely" an evening type people by the Horne and Ostberg's circadian typology questionnaire (delayed phase subject)
• •4. Whose sleep disorders are related to external factors (noise pollution, young children, etc ...)
• •5. Workers with atypical schedules (night work, staggered working hours, changes in regular working hours, or shift work)
• •6. Smoker
• •7. Drug Addict
• •8. Alcohol consumption greater than 2 glasses per day
• •9. Subject with excessive caffeine consumption exceeding 400 mg per day (coffee ≈ 80 mg per cup; cola soda≈ 25 mg per glass; tea ≈40 mg per cup; energy drinks ≈70 mg per glass)
• •10. Subject consuming or having consumed any dietary supplement with an effect or a possible effect on sleep, stress, anxiety, or fatigue during the last 3 months prior to screening visit (melatonin, lactium, ginseng, caffeine ...)
• •11. Subject who has been treated during the 6 months preceding the screening visit or are currently being treated with non-medication therapies (such as psychotherapy, Cognitive Behavioral Therapy \[CBT\], Eye Movement Desensitization and Reprocessing \[EMDR\], etc. or repetitive Transcranial Magnetic Stimulation \[TMS\]) or psychotropic medication prescribed and / or recommended for anxious manifestations, depression, sleep disorders and generally for any neurological or psychological manifestation
• •12. Subject with psychiatric comorbidity as described in the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) (depression, post traumatic stress disorder, etc.) or history of psychiatric illness
• •13. Untreated or not controlled hypertension
• •14. Untreated or not controlled thyroid diseases (hypo or hyperthyroidism, Graves' disease...)
• •15. Epileptic subject
• •16. Asthmatic subject
• •17. Any other pathology or medical history or symptomatology likely to significantly influence the study criteria (nocturnal pain, nasal congestion, cough at bedtime or nocturnal cough, nocturnal pollakiuria, tinnitus, etc.) according to the investigator
• •18. Confirmed cow's milk protein allergy
• •19. Sleeping on a mattress that is not compatible with the sleep quality recording (water and air mattresses) or does not have adequate or necessary domestic equipment for its operation (power socket near the bed, etc.)
• •20. Likely to sleep outside their home during the study (holidays, regular business trips, etc.)
• •21. Whose spouse or partner is participating in this study
• •22. Pregnant woman (negative urine test at screening and initial/randomization visits) or wishing to be pregnant during the study or breastfeeding
• •23. Hormonal state that may induce fluctuation in emotional state and sleep during the study, such as, the postpartum period (\< 6 months after delivery) and perimenopause (irregular menstrual cycle, hot flashes)
• •24. Under legal protection (guardianship, curatorship) or deprived of rights following an administrative or judicial decision
• •25. Psychologically or linguistically incapable of understanding and signing informed consent
• •26. Participating in another clinical trial or in exclusion period of a previous clinical trial
• •27. Having reached the maximum research compensation threshold stipulated by regulations.