Not Yet RecruitingNot Applicable

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

100 participantsStarted 2024-06-10

Plain-language summary

The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia.

Age range25 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Presenting moderate to severe insomnia defined by an ISI score greater than or equal to 15 in the last month prior to selection
✕. Presenting other sleep disorders already diagnosed or suspected during the screening visit: impatience (restless legs), parasomnias, hypersomnias, sleep apnea, iatrogenic insomnia
✕. Subject assessed as "definitely" an evening type people by the Horne and Ostberg's circadian typology questionnaire (delayed phase subject)
✕. Whose sleep disorders are related to external factors (noise pollution, young children, etc ...)
✕. Workers with atypical schedules (night work, staggered working hours, changes in regular working hours, or shift work)
✕. Smoker
✕. Drug Addict
✕. Alcohol consumption greater than 2 glasses per day

Sleep efficiency

Timeframe: Before treatment (day 0); at the end of the treatment (after 29 days)

NCT IDNCT06378034

SponsorIngredia S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-15