Sleep
Conditions
Keywords
melatonin, lotion
Brief summary
The goal of this clinical trial is to test an over-the-counter sleep lotion in healthy undergraduate college students. The main questions it aims to answer are: * Does an over-the-counter sleep lotion containing melatonin actually increase melatonin levels in participants compared to a placebo (control) lotion? * Does an over-the-counter sleep lotion containing melatonin improve the quality of participants' sleep compared to a placebo (control) lotion? Participants will: * provide three saliva samples on each of two nights * apply melatonin-containing sleep lotion on one night and a placebo (control with no melatonin) lotion on the other night * answer questionnaires about gender, race, ethnicity, medication use, exercise, and sleep quality
Detailed description
Melatonin is a hormone secreted by the pineal gland in the brain that regulates sleep. There are many over-the-counter products such as bubble baths, room sprays, and lotions that claim they contain melatonin and promote sleep. This study is a randomized, controlled, double-blind crossover trial to compare the impact of a commercial sleep lotion vs. a control lotion on melatonin levels detectable in saliva in healthy undergraduate students. Participants will provide saliva samples on two nights, one week apart, one hour before bedtime. The sample collections will take place just before and twice after applying 1) a melatonin lotion and 2) a placebo control lotion (order randomized). The investigators will determine whether the melatonin lotion affects the natural rise of melatonin before bedtime. A second dependent variable will be the quality of sleep on both nights. Potential confounding independent variables, such as gender, race, ethnicity, medication use, and exercise will also be assessed.
Interventions
OTHERMelatonin sleep lotion
7 g of lotion applied to hands and arms one hour before bedtime
OTHERPlacebo control lotion
7 g of lotion applied to hands and arms one hour before bedtime
Sponsors
University of Redlands
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized to either the melatonin lotion first or the placebo control lotion first, and then each participant will receive the other treatment second.
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 to 24 years old * current University of Redlands student
Exclusion criteria
* Pregnancy * currently taking any sleep medications * allergies or sensitivities to scented lotion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary melatonin | Three samples over an hour: pre-lotion application (one hour before bedtime), 30 minutes after lotion application, and one hour after lotion application (at bedtime). This 1 hr sampling will happen on two separate nights within a week of enrollment. | pg/ml of melatonin in saliva measured by enzyme-linked immunosorbent assay |
| Sleep Quality | A 15 minute questionnaire taken each morning after lotion application and saliva sampling. These two mornings are both within a week of enrollment (specific dates chosen by participant). | Modified Pittsburgh Sleep Quality Index. Scores from 0 (good sleep quality) to 14 (poor sleep quality) |
Countries
United States
Outcome results
None listed