MedTrace Logo

Optimization of Melatonin Administration in Healthy Adults

NCT07514507 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-04-07

No results posted yet for this 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

Conditions

  • Sleep Disorders

Interventions

DIETARY_SUPPLEMENT

Mel 2 mg 30 min

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

DIETARY_SUPPLEMENT

Mel 2 mg 3 h

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

DIETARY_SUPPLEMENT

Mel 4 mg 30 min

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

DIETARY_SUPPLEMENT

Mel 4 mg 3 h

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

OTHER

Placebo

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

Sponsors & Collaborators

  • IRCCS Fondazione Stella Maris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07514507 on ClinicalTrials.gov