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The Impact of Melatonin Lotion on Sleep and Mental Health

RecruitingNAAges 18 Years - 21 YearsAllUniversity of Redlands
NCT06768749 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. The goal is to determine whether melatonin in lotion form is an effective treatment for young adults with inadequate sleep and might improve mental health. Participants will fill out surveys, wear an actigraph (a wrist-worn device that measures sleep), wear a heart rate monitor (a strap worn around one's chest), and provide nightly saliva samples during treatment weeks. In one of the two treatment weeks, participants will receive a lotion that contains melatonin. During the other week they will receive a control treatment that will be lotion with no melatonin, and there will be a week in between with no treatment at all.

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📋 Eligibility rules (as published)
Inclusion Criteria: * a T score ≥ 48 on the sleep disturbance short form Patient-Reported Outcomes Measurement Information System (PROMIS) measure, and * a T score ≥ 55 on the anxiety or depression short form PROMIS measures (mild symptoms or more) Exclusion Criteria: * currently using antidepressant, anti-anxiety, or sleep medication including melatonin * are pregnant * have allergies/sensitivities to scented lotion * are unwilling to commit to keeping a similar bedtime (± 1 hour) during treatment weeks.
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What it tests

  • Melatonin lotion
  • Placebo lotion
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Where

1 site
University of Redlands
Redlands, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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