Status:
RECRUITING
Melatonin Adolescent Research Study
Lead Sponsor:
Loma Linda University
Conditions:
Sleep Disorders in Children
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief Summary
The present study will use a within-person, randomized cross-over experimental design to test the effects of exogenous melatonin supplementation on the sleep and daytime functioning of typically devel...
Eligibility Criteria
Inclusion Criteria:
- Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).
- Ages 13 to 17 years old
- Able to understand, read, and write in English
- Melatonin naive
Exclusion Criteria:
- Obesity
- Use of psychiatric medication
- Drug(s), or supplements known to affect sleep
- History of head injury or concussion with loss of consciousness >1 minute
- Daily consumption of >1 caffeinated beverage
- Risk for any organic sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome)
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04588233
Start Date
September 15 2021
End Date
May 1 2026
Last Update
January 30 2026
Active Locations (2)
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1
Loma Linda University
Loma Linda, California, United States, 92350
2
Loma Linda U
Loma Linda, California, United States, 92354