University of Pisa, Institute of Physiology, Sonnolab
Pisa, PI, 56126, Italy
NCT Number: NCT07514507
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 opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Not applicable
Pisa, PI, 56126, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Melatonin 2 mg 30 minutes before bedtime, placebo 3 hours before bedtime
Placebo administered 30 minutes before bedtime, melatonin 2 mg administered 3 hours before bedtime
Melatonin 4 mg administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
Placebo administered 30 minutes before bedtime, melatonin 4 mg administered 3 hours before bedtime
Placebo administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
Time frame: First night following administration of the drug
Time required to fall asleep assessed using polisomnography
Time frame: First night following administration of the drug
Night sleep duration assessed using polisomnography
Time frame: First night following administration of the drug
Ratio between total sleep time and time in bed
Time frame: First night following administration of the drug
Minutes spent awake between the sleep onset and morning awakening
Contact information is provided by the study sponsor or research team.
IRCCS Fondazione Stella Maris
Other
Optimizing Timing and Dose of Melatonin Administration: a Randomized, Double-blind Controlled Trial in Healthy Adults
Acronym: MelOpt
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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