Trials / Recruiting
RecruitingNCT04588233
Melatonin Adolescent Research Study
Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Loma Linda University · Academic / Other
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Not accepted
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 developing adolescents with short or disrupted sleep of behavioral origins (i.e., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep not attributed to an organic sleep condition).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Melatonin | Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights |
| OTHER | Placebo | Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights |
Timeline
- Start date
- 2021-09-15
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2020-10-19
- Last updated
- 2026-01-30
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04588233. Inclusion in this directory is not an endorsement.