Optimization of Melatonin Administration in Healthy Adults
Condition(s) studied
Investigational drug(s) / intervention(s)
Mel 2 mg 30 min: Melatonin 2 mg 30 minutes before bedtime, placebo 3 hours before bedtime
Mel 2 mg 3 h: Placebo administered 30 minutes before bedtime, melatonin 2 mg administered 3 hours before bedtime
Mel 4 mg 30 min: Melatonin 4 mg administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
Mel 4 mg 3 h: Placebo administered 30 minutes before bedtime, melatonin 4 mg administered 3 hours before bedtime
Placebo: Placebo administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
Study summary
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
Eligibility
Primary outcome measure(s)
- Sleep Onset Latency — First night following administration of the drug
Time required to fall asleep assessed using polisomnography
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Pisa, Institute of Physiology, Sonnolab | Pisa | PI |
More IRCCS Fondazione Stella Maris trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07514507 on ClinicalTrials.gov ↗ ← All trials in Italy