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NCT Number: NCT07514507

Optimization of Melatonin Administration in Healthy Adults

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 45 years of age
  • Fluent knowledge of Italian language
  • Review and signing of the informed consent form

Exclusion criteria

  • Diagnosis of sleep or circadian rhythm disorder
  • Diagnosis of neurological, psychiatric or medical condition that may interfere with sleep
  • Ongoing treatment with medications that may affect sleep, including hypnotics and other types of melatonin
  • Travel to a country with a time zone difference of at least two hours within the two months prior to or during the study
  • Shift work
  • Confirmed pregnancy
  • Breastfeeding

Treatment and study plan

Mel 2 mg 30 min

Dietary Supplement

Melatonin 2 mg 30 minutes before bedtime, placebo 3 hours before bedtime

Mel 2 mg 3 h

Dietary Supplement

Placebo administered 30 minutes before bedtime, melatonin 2 mg administered 3 hours before bedtime

Mel 4 mg 30 min

Dietary Supplement

Melatonin 4 mg administered 30 minutes before bedtime, placebo administered 3 hours before bedtime

Mel 4 mg 3 h

Dietary Supplement

Placebo administered 30 minutes before bedtime, melatonin 4 mg administered 3 hours before bedtime

Placebo

Other

Placebo administered 30 minutes before bedtime, placebo administered 3 hours before bedtime

Primary outcomes

  1. Sleep Onset Latency

    Time frame: First night following administration of the drug

    Time required to fall asleep assessed using polisomnography

Secondary outcomes

  1. Total Sleep Time

    Time frame: First night following administration of the drug

    Night sleep duration assessed using polisomnography

  2. Sleep Efficiency

    Time frame: First night following administration of the drug

    Ratio between total sleep time and time in bed

  3. Wake After Sleep Onset

    Time frame: First night following administration of the drug

    Minutes spent awake between the sleep onset and morning awakening

Study contacts

Contact information is provided by the study sponsor or research team.

Ugo Faraguna, MD, PhD

CONTACT

[email protected]

+39 050 2213470

Sponsors and collaborators

Lead sponsor

IRCCS Fondazione Stella Maris

Other

Registry information

Official study title

Optimizing Timing and Dose of Melatonin Administration: a Randomized, Double-blind Controlled Trial in Healthy Adults

Acronym: MelOpt

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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