The Impact of Melatonin Lotion on Sleep and Mental Health

University of Redlands

Status: Enrolling

Conditions: Sleep Problems; Depressive Disorder and Anxiety Disorders

Treatments: Other: Placebo lotion; Other: Melatonin lotion

Study type: Interventional

Funder types: Other

Identifiers

NCT06768749

2024-032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Melatonin lotion first

Experimental group

Description:

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

Treatment:

Other: Melatonin lotion

Other: Placebo lotion

Placebo lotion first

Experimental group

Description:

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

Treatment:

Other: Melatonin lotion

Other: Placebo lotion