NCT06768749 · University of Redlands
The Impact of Melatonin Lotion on Sleep and Mental Health
What this study is about
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.
View original scientific description
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 outcome measures
Sleep disturbance
Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
PROMIS SF v1.0 - Sleep Disturb 8b
Anxiety
Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
PROMIS SF v1.0 - Anxiety 8a
Depression
Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
PROMIS SF v1.0 - Depression 8b
Total sleep time
Time frame: Two weeks of data separated by a one week period
Measured via actigraphy
Sleep efficiency
Time frame: Two weeks of data separated by a one week period
Measured by actigraphy
Normalized high frequency power of heart rate variability
Time frame: Two weeks of data separated by a one week period
5 min period during sleep latency, overnight recording while sleeping, and 5 min period sitting upright each morning
Anxiety by momentary ecological assessment
Time frame: Three times per day for two weeks of data separated by a one week period
One item question: "How anxious do you feel right now?"
Mood by momentary ecological assessment
Time frame: Three times per day for two weeks of data separated by a one week period
Single-item questions ("How \_\_\_ do you feel right now?)
Salivary alpha-amylase
Time frame: Daily at bedtime for two weeks of data separated by a one week period
As an indicator of sympathetic nervous system activity
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Redlands, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations