The Impact of Melatonin Lotion on Sleep and Mental Health

NCT06768749 | Recruiting

• 1 other identifier: 2024-032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Problems; Depressive Disorder and Anxiety Disorders

Keywords

melatonin; sleep; heart rate variability; actigraphy; amylase; mood; anxiety; depression

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• Sleep-related impairment

  Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)

• Other sleep variables

  Two weeks of data separated by a one week period

• Salivary melatonin

  Daily at bedtime for two weeks of data separated by a one week period

• Other HRV variables

  5 min period sitting upright each morning after waking, and overnight data capture starting one hour before bedtime

• Side effects

  Daily for two weeks of data separated by a one week period

Study Arms (2)

Melatonin lotion first

EXPERIMENTAL

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; Other: Placebo lotion

Placebo lotion first

EXPERIMENTAL

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; Other: Placebo lotion

Interventions

Melatonin lotion OTHER

3 g lotion applied one hour before bedtime

Melatonin lotion first; Placebo lotion first

Placebo lotion OTHER

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

Melatonin lotion first; Placebo lotion first

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Redlands: lead

Study Sites (1)

University of Redlands

Redlands, California, 92374, United States

RECRUITING

MeSH Terms

Conditions

Parasomnias; Depressive Disorder; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lisa E Olson, Ph.D.

  University of Redlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa E Olson, Ph.D.

CONTACT

909-748-8524; lisa_olson@redlands.edu

Steven Moore, Ph.D.

CONTACT

(909) 748-8687; steven_moore@redlands.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biology

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be submitted after publication of the main study outcomes, and will remain on the National Sleep Research Resource server indefinitely
• Access Criteria: Data will be provided via the National Sleep Research Resource and access allowed according to their criteria

Locations

US (1)