The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sleep disturbance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 21 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Melatonin lotion first
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
干预措施: Melatonin lotion (Other)
Melatonin lotion first
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
干预措施: Placebo lotion (Other)
Placebo lotion first
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
干预措施: Melatonin lotion (Other)
Placebo lotion first
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
干预措施: Placebo lotion (Other)
结局指标
主要结局
Sleep disturbance
时间窗: 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
时间窗: 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
时间窗: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
PROMIS SF v1.0 - Depression 8b
Total sleep time
时间窗: Two weeks of data separated by a one week period
Measured via actigraphy
Sleep efficiency
时间窗: Two weeks of data separated by a one week period
Measured by actigraphy
Normalized high frequency power of heart rate variability
时间窗: 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
Anxiety by momentary ecological assessment
时间窗: 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
时间窗: 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
时间窗: Daily at bedtime for two weeks of data separated by a one week period
As an indicator of sympathetic nervous system activity
次要结局
- Sleep-related impairment(Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total))
- Other sleep variables(Two weeks of data separated by a one week period)
- Salivary melatonin(Daily at bedtime for two weeks of data separated by a one week period)
- Other HRV variables(5 min period sitting upright each morning after waking, and overnight data capture starting one hour before bedtime)
- Side effects(Daily for two weeks of data separated by a one week period)
研究者
Lisa Olson
Professor of Biology
University of Redlands