Impact of Commercial Sleep Lotion on Salivary Melatonin Levels and Sleep Quality in Undergraduates

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Commercial Sleep Lotion on Salivary Melatonin Levels and Sleep Quality in Undergraduates

Conditions
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Sleep

Intervention / Treatment
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* Other: Melatonin sleep lotion
* Other: Placebo control lotion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin sleep lotion Night 1; Placebo control lotion Night 2<br>Participants in this arm received melatonin-containing sleep lotion to apply on the first night of saliva sampling. On the second night of saliva sampling, they received placebo control lotion. | Other: Melatonin sleep lotion<br>* 7 g of lotion applied to hands and arms one hour before bedtime<br>* Other names: Dr. Teal's Sleep Lotion;Other: Placebo control lotion<br>* 7 g of lotion applied to hands and arms one hour before bedtime<br>* Other names: Dr. Teal's Lavender Essential Oils Lotion;|
| Experimental: Placebo control lotion Night 1; Melatonin sleep lotion Night 2<br>Participants in this arm received placebo control lotion to apply on the first night of saliva sampling. On the second night of saliva sampling, they received melatonin-containing sleep lotion. | Other: Melatonin sleep lotion<br>* 7 g of lotion applied to hands and arms one hour before bedtime<br>* Other names: Dr. Teal's Sleep Lotion;Other: Placebo control lotion<br>* 7 g of lotion applied to hands and arms one hour before bedtime<br>* Other names: Dr. Teal's Lavender Essential Oils Lotion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary melatonin | pg/ml of melatonin in saliva measured by enzyme-linked immunosorbent assay | 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. | 
| Sleep Quality | Modified Pittsburgh Sleep Quality Index. Scores from 0 (good sleep quality) to 14 (poor 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, lotion