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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin lotion first | Experimental | 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 |
|
| Placebo lotion first | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin lotion | Other | 3 g lotion applied one hour before bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep disturbance | PROMIS SF v1.0 - Sleep Disturb 8b | Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total) |
| Anxiety | PROMIS SF v1.0 - Anxiety 8a | Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total) |
| Depression | PROMIS SF v1.0 - Depression 8b | Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total) |
| Total sleep time | Measured via actigraphy | Two weeks of data separated by a one week period |
| Sleep efficiency | Measured by actigraphy | Two weeks of data separated by a one week period |
| Normalized high frequency power of heart rate variability | 5 min period during sleep latency, overnight recording while sleeping, and 5 min period sitting upright each morning | Two weeks of data separated by a one week period |
| Anxiety by momentary ecological assessment | One item question: "How anxious do you feel right now?" | Three times per day for two weeks of data separated by a one week period |
| Mood by momentary ecological assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep-related impairment | PROMIS SF v1.0 - Sleep-Related Impairment 8a | Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total) |
| Other sleep variables |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa E Olson, Ph.D. | Contact | 909-748-8524 | lisa_olson@redlands.edu | |
| Steven Moore, Ph.D. | Contact | (909) 748-8687 | steven_moore@redlands.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa E Olson, Ph.D. | University of Redlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Redlands | Recruiting | Redlands | California | 92374 | United States |
All IPD (deidentified through the safe harbor method)
Data will be submitted after publication of the main study outcomes, and will remain on the National Sleep Research Resource server indefinitely
Data will be provided via the National Sleep Research Resource and access allowed according to their criteria
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
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| Placebo lotion | Other | 3 g of placebo lotion (scent-matched control) applied one hour before bedtime |
|
Single-item questions ("How ___ do you feel right now?) |
| Three times per day for two weeks of data separated by a one week period |
| Salivary alpha-amylase | As an indicator of sympathetic nervous system activity | Daily at bedtime for 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
| Two weeks of data separated by a one week period |
| Salivary melatonin | For confirmation of protocol compliance | Daily at bedtime for two weeks of data separated by a one week period |
| Other HRV variables | 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 min period sitting upright each morning after waking, and overnight data capture starting one hour before bedtime |
| Side effects | Frequency of headache, drowsiness, skin irritation, vivid dreams, nightmares, dizziness, and other | Daily for two weeks of data separated by a one week period |
| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |