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Optimization of Melatonin Administration in Healthy Adults

Study acronym: MelOpt
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 7, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
The goal of this clinical trial is to evaluate whether the timing and dosage of exogenous melatonin can improve sleep onset and maintenance in healthy adults aged 18-45 years (50% female) with no history of sleep disorders. The main questions it aims to answer is whether an optimized melatonin administration schedule (4 mg, 3 hours before bedtime) will be more effective in improving sleep initiation and maintenance than an administration schedule more commonly advised (2 mg, 30 minutes before bedtime). Researchers will compare five conditions involving different combinations of melatonin or placebo administered 30 minutes or 3 hours before bedtime to see if earlier timing and/or higher dosage produces better sleep outcomes. Participants will: * Complete a habituation night without any intervention. * Undergo five randomized, double-blind experimental sleep conditions including: 2 mg melatonin 30 minutes before bedtime 2 mg melatonin 3 hours before bedtime 4 mg melatonin 30 minutes before bedtime 4 mg melatonin 3 hours before bedtime Placebo at both time points * Be monitored via polysomnography to measure sleep parameters
Trial Details
NCT Number NCT07514507
Lead Sponsor IRCCS Fondazione Stella Maris
Conditions
(from sponsor)
Sleep Disorders
Related terms Sleep Wake Disorders
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov