Recruiting

The Impact of Melatonin Lotion on Sleep and Mental Health

ClinicalTrials.gov IDNCT06768749

PhaseNA

Enrollment60

SponsorUniversity of Redlands

Age18 Years

SexALL

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Conditions studied

Sleep Problems, Depressive Disorder and Anxiety Disorders

About this study

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.

Interventions

Other: Melatonin lotion — 3 g lotion applied one hour before bedtime
Other: Placebo lotion — 3 g of placebo lotion (scent-matched control) applied one hour before bedtime

Primary outcomes

Sleep disturbance (Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total))
Anxiety (Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total))
Depression (Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total))
Total sleep time (Two weeks of data separated by a one week period)
Sleep efficiency (Two weeks of data separated by a one week period)
Normalized high frequency power of heart rate variability (Two weeks of data separated by a one week period)
Anxiety by momentary ecological assessment (Three times per day for two weeks of data separated by a one week period)
Mood by momentary ecological assessment (Three times per day for two weeks of data separated by a one week period)

Eligibility information

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.

Study locations

University of Redlands, Redlands, California 92374 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.