Optimization of Melatonin Administration in Healthy Adults
ConditionSleep Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorIRCCS Fondazione Stella Maris
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 45 years of age
Fluent knowledge of Italian language
Review and signing of the informed consent form
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Mel 2 mg 30 min
Dietary supplementMelatonin 2 mg 30 minutes before bedtime, placebo 3 hours before bedtime
Mel 2 mg 3 h
Dietary supplementPlacebo administered 30 minutes before bedtime, melatonin 2 mg administered 3 hours before bedtime
Mel 4 mg 30 min
Dietary supplementMelatonin 4 mg administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
Mel 4 mg 3 h
Dietary supplementPlacebo administered 30 minutes before bedtime, melatonin 4 mg administered 3 hours before bedtime
Placebo
Other interventionPlacebo administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
Treatment groups
14 Participants
are divided into 5 treatment groupsGroup A: 2mg 30minActive comparator 1 intervention
Group B: 2mg 3hExperimental treatment 1 intervention
Group C: 4mg 30minExperimental treatment 1 intervention
Group D: 4mg 3hExperimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Onset Latency
Time required to fall asleep assessed using polisomnography
Time frame
First night following administration of the drugSecondary outcomes
1
Total Sleep Time
Night sleep duration assessed using polisomnography
Time frame
First night following administration of the drug2
Sleep Efficiency
Ratio between total sleep time and time in bed
Time frame
First night following administration of the drug3
Wake After Sleep Onset
Minutes spent awake between the sleep onset and morning awakening
Time frame
First night following administration of the drugSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: