Sleep Problems, Depressive Disorder and Anxiety Disorders
Conditions
Keywords
melatonin, sleep, heart rate variability, actigraphy, amylase, mood, anxiety, depression
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.
Interventions
OTHERMelatonin lotion
3 g lotion applied one hour before bedtime
OTHERPlacebo lotion
3 g of placebo lotion (scent-matched control) applied one hour before bedtime
Sponsors
University of Redlands
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactLisa E Olson, Ph.D.
Backup ContactSteven Moore, Ph.D.
Outcome results
None listed