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

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder and Anxiety Disorders; Sleep Problems
• Intervention / Treatment: Other: Melatonin lotion; Other: Placebo lotion

Detailed Description

All participants will receive a melatonin lotion and a placebo lotion in a randomized crossover design. Participants will receive equipment and supplies on a Monday and will begin the assigned treatment that night, by self-applying premeasured lotion 1 hour before bedtime. During the two treatment weeks, participants will wear ActiGraph GT3X-BT accelerometers (ActiGraph, Pensacola, FL) at all times except when bathing or submerged in water. They will wear Polar H10 heart rate monitor chest straps (Polar Electro, Kempele, Finland) from one hour prior to bedtime until after a 5 min sitting period after waking. Three times daily they will be asked 1-item mood/anxiety questions ("How ___ do you feel right now?") through REDCap software. Participants will check any experienced side effects off a checklist once daily. Participants will collect a passive drool sample daily at bedtime and store in their home freezer until returning the samples to the laboratory. Treatment will occur for seven nights, with a return of equipment and saliva samples as well as confirmation of actigraphy and HRV readings the following Monday. After a seven day washout period to reduce any carryover effects, equipment and supplies will be supplied the next Monday and the participant will begin the other assigned treatment (active or placebo) that night in a crossover design. At three timepoints (pre-treatment, at the end of the melatonin treatment week, and at the end of the placebo week), participants will answer the following surveys online via REDCap: PROMIS short forms for anxiety, depression, sleep quality, and sleep-related impairment.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa E Olson, Ph.D.; Phone Number: 909-748-8524; Email: lisa_olson@redlands.edu
• Study Contact Backup: Name: Steven Moore, Ph.D.; Phone Number: (909) 748-8687; Email: steven_moore@redlands.edu

Study Locations

• United States
  • California
    • Redlands, California, United States, 92374
      • Recruiting
      • University of Redlands
      • Contact: Lisa Olson, Ph.D.; Phone Number: 909-748-8524; Email: lisa_olson@redlands.edu
      • Principal Investigator: Lisa Olson, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melatonin lotion first; Participants will be randomized to one week of treatment with melatonin lotion, followed by a week washout, then one week of treatment with placebo lotion	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
Experimental: Placebo lotion first; Participants will be randomized to one week of treatment with placebo lotion, followed by a week washout, then one week of treatment with melatonin lotion	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep disturbance	PROMIS SF v1.0 - Sleep Disturb 8b	Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
Anxiety	PROMIS SF v1.0 - Anxiety 8a	Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
Depression	PROMIS SF v1.0 - Depression 8b	Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
Total sleep time	Measured via actigraphy	Two weeks of data separated by a one week period
Sleep efficiency	Measured by actigraphy	Two weeks of data separated by a one week period
Normalized high frequency power of heart rate variability	5 min period during sleep latency, overnight recording while sleeping, and 5 min period sitting upright each morning	Two weeks of data separated by a one week period
Anxiety by momentary ecological assessment	One item question: "How anxious do you feel right now?"	Three times per day for two weeks of data separated by a one week period
Mood by momentary ecological assessment	Single-item questions ("How ___ do you feel right now?)	Three times per day for two weeks of data separated by a one week period
Salivary alpha-amylase	As an indicator of sympathetic nervous system activity	Daily at bedtime for two weeks of data separated by a one week period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep-related impairment	PROMIS SF v1.0 - Sleep-Related Impairment 8a	Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
Other sleep variables	A MANOVA will be conducted with the primary sleep outcomes as well as sleep onset latency (both self-reported and as measured by actigraphy) and subjective sleep quality	Two weeks of data separated by a one week period
Salivary melatonin	For confirmation of protocol compliance	Daily at bedtime for two weeks of data separated by a one week period
Other HRV variables	A MANOVA will be conducted with autonomic nervous system indicators including normalized high frequency HRV and salivary alpha amylase as primary outcomes, but also including LF/HF ratio, RMSSD, and pNN50	5 min period sitting upright each morning after waking, and overnight data capture starting one hour before bedtime
Side effects	Frequency of headache, drowsiness, skin irritation, vivid dreams, nightmares, dizziness, and other	Daily for two weeks of data separated by a one week period

Collaborators and Investigators

• Sponsor: University of Redlands
• Investigators: Principal Investigator: Lisa E Olson, Ph.D., University of Redlands

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sleep; melatonin; depression; anxiety; heart rate variability; mood; actigraphy; amylase
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Mood Disorders; Behavior; Anxiety Disorders; Parasomnias; Depression; Depressive Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antioxidants; Protective Agents; Melatonin
• Other Study ID Numbers: 2024-032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD (deidentified through the safe harbor method)
• IPD Sharing Time Frame: Data will be submitted after publication of the main study outcomes, and will remain on the National Sleep Research Resource server indefinitely
• IPD Sharing Access Criteria: Data will be provided via the National Sleep Research Resource and access allowed according to their criteria
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No