TrialPath
Recruiting

The Impact of Melatonin Lotion on Sleep and Mental Health

NCT06768749 · University of Redlands
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects
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.
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.
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: triple
Age groups: adult
Timeline
Starts: 2025-02-28
Estimated completion: 2028-04-01
Last updated: 2026-05-01
Interventions
Other: Melatonin lotionOther: Placebo lotion
Primary outcomes
  • Sleep disturbance (Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total))
  • Anxiety (Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total))
  • Depression (Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total))
Sponsor
University of Redlands · other
Contacts & investigators
ContactLisa E Olson, Ph.D. · contact · lisa_olson@redlands.edu · 909-748-8524
ContactSteven Moore, Ph.D. · contact · steven_moore@redlands.edu · (909) 748-8687
InvestigatorLisa E Olson, Ph.D. · principal_investigator, University of Redlands
All locations (1)
University of RedlandsRecruiting
Redlands, California, United States