RecruitingNot ApplicableNCT06768749

The Impact of Melatonin Lotion on Sleep and Mental Health

The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects


Sponsor

University of Redlands

Enrollment

60 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 21 Years

Inclusion Criteria2

  • 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 Criteria4

  • 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.

Interventions

OTHERMelatonin lotion

3 g lotion applied one hour before bedtime

OTHERPlacebo lotion

3 g of placebo lotion (scent-matched control) applied one hour before bedtime


Locations(1)

University of Redlands

Redlands, California, United States

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NCT06768749


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