The Impact of Melatonin Lotion on Sleep and Mental Health

Not Applicable

Recruiting

• Conditions: Sleep Problems; Depressive Disorder and Anxiety Disorders

• Registration Number: NCT06768749
• Lead Sponsor: University of Redlands

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.

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Study Start: 2025-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2028-04-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Sleep disturbance	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	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	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	Two weeks of data separated by a one week period	Measured via actigraphy
Sleep efficiency	Two weeks of data separated by a one week period	Measured by actigraphy
Normalized high frequency power of heart rate variability	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	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	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	Daily at bedtime for two weeks of data separated by a one week period	As an indicator of sympathetic nervous system activity

Secondary Outcome Measures

Name	Time	Method
Sleep-related impairment	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
Other sleep variables	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
Salivary melatonin	Daily at bedtime for two weeks of data separated by a one week period	For confirmation of protocol compliance
Other HRV variables	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
Side effects	Daily for two weeks of data separated by a one week period	Frequency of headache, drowsiness, skin irritation, vivid dreams, nightmares, dizziness, and other

Trial Locations

Locations (1)

University of Redlands; 🇺🇸 Redlands, California, United States