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NCT Number: NCT06768749

The Impact of Melatonin Lotion on Sleep and Mental Health

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.

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Key information

Conditions

Sleep Problems Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder and Anxiety Disorders Mental Disorders Mood Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

18 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Redlands

Redlands, California, 92374, United States

Location status: Recruiting

Location contact

Lisa Olson, Ph.D.

CONTACT

[email protected]

909-748-8524

Lisa Olson, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin lotion

Other

3 g lotion applied one hour before bedtime

Placebo Lotion

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Total sleep time

    Time frame: Two weeks of data separated by a one week period

    Measured via actigraphy

  5. Sleep efficiency

    Time frame: Two weeks of data separated by a one week period

    Measured by actigraphy

  6. 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

  7. 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?"

  8. 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?)

  9. 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

Secondary outcomes

  1. Sleep-related impairment

    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-Related Impairment 8a

  2. Other sleep variables

    Time frame: Two weeks of data separated by a one week period

    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

  3. Salivary melatonin

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

    For confirmation of protocol compliance

  4. Other HRV variables

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

    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. Side effects

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

    Frequency of headache, drowsiness, skin irritation, vivid dreams, nightmares, dizziness, and other

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa E Olson, Ph.D.

CONTACT

[email protected]

909-748-8524

Steven Moore, Ph.D.

CONTACT

[email protected]

(909) 748-8687

Sponsors and collaborators

Lead sponsor

University of Redlands

Other

Registry information

Official study title

The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 10, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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