Sleep Disorders
Conditions
Keywords
melatonin, sleep health, sleep drugs, hypnotics and sedatives, drug administration schedule
Brief 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
Interventions
DIETARY_SUPPLEMENTMel 2 mg 30 min
Melatonin 2 mg 30 minutes before bedtime, placebo 3 hours before bedtime
DIETARY_SUPPLEMENTMel 2 mg 3 h
Placebo administered 30 minutes before bedtime, melatonin 2 mg administered 3 hours before bedtime
DIETARY_SUPPLEMENTMel 4 mg 30 min
Melatonin 4 mg administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
DIETARY_SUPPLEMENTMel 4 mg 3 h
Placebo administered 30 minutes before bedtime, melatonin 4 mg administered 3 hours before bedtime
OTHERPlacebo
Placebo administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
Sponsors
IRCCS Fondazione Stella Maris
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency | First night following administration of the drug | Time required to fall asleep assessed using polisomnography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time | First night following administration of the drug | Night sleep duration assessed using polisomnography |
| Sleep Efficiency | First night following administration of the drug | Ratio between total sleep time and time in bed |
| Wake After Sleep Onset | First night following administration of the drug | Minutes spent awake between the sleep onset and morning awakening |
Countries
Italy
Contacts
CONTACTUgo Faraguna, MD, PhD
Outcome results
None listed