The Impact of Melatonin Lotion on Sleep and Mental Health

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Sleep disturbance [Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)]
• Anxiety [Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)]
• Depression [Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)]
• Total sleep time [Time frame: Two weeks of data separated by a one week period]
• Sleep efficiency [Time frame: Two weeks of data separated by a one week period]
• Normalized high frequency power of heart rate variability [Time frame: Two weeks of data separated by a one week period]
• Anxiety by momentary ecological assessment [Time frame: Three times per day for two weeks of data separated by a one week period]
• Mood by momentary ecological assessment [Time frame: Three times per day for two weeks of data separated by a one week period]
• Salivary alpha-amylase [Time frame: Daily at bedtime for two weeks of data separated by a one week period]

Secondary outcome measures (5)

• Sleep-related impairment [Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)]
• Other sleep variables [Time frame: Two weeks of data separated by a one week period]
• Salivary melatonin [Time frame: Daily at bedtime for two weeks of data separated by a one week period]
• Other HRV variables [Time frame: 5 min period sitting upright each morning after waking, and overnight data capture starting one hour before bedtime]
• Side effects [Time frame: Daily for two weeks of data separated by a one week period]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Redlands — Redlands

Identifiers

NCT: NCT06768749 · 2024-032

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗