The Impact of Melatonin Lotion on Sleep and Mental Health

NCT ID: NCT06768749

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2028-04-01

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.

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.

Conditions

Sleep Problems; Depressive Disorder and Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Melatonin lotion

Intervention Type: OTHER

3 g lotion applied one hour before bedtime

Placebo lotion

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Melatonin lotion

Intervention Type: OTHER

3 g lotion applied one hour before bedtime

Placebo lotion

Intervention Type: OTHER

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

Interventions

Melatonin lotion

3 g lotion applied one hour before bedtime

Intervention Type: OTHER

Placebo lotion

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Redlands

OTHER

Sponsor Role: lead

Responsible Party

Lisa Olson

Professor of Biology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa E Olson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Redlands

Locations

University of Redlands

Redlands, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lisa E Olson, Ph.D.

Role: CONTACT

lisa_olson@redlands.edu

909-748-8524

Steven Moore, Ph.D.

Role: CONTACT

steven_moore@redlands.edu

(909) 748-8687

Facility Contacts

Lisa Olson, Ph.D.

Role: primary

lisa_olson@redlands.edu

909-748-8524

Other Identifiers

2024-032

Identifier Type: -

Identifier Source: org_study_id