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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin sleep lotion Night 1; Placebo control lotion Night 2 | Experimental | 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. |
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| Placebo control lotion Night 1; Melatonin sleep lotion Night 2 | Experimental | 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." |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin sleep lotion | Other | 7 g of lotion applied to hands and arms one hour before bedtime |
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| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Olson, Ph.D. | University of Redlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Redlands | Redlands | California | 92373 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39146562 | Derived | Ponce C, Razon AD, Chao J, Nakagawa SK, Peterson MM, Roque AY, Vanderpool MA, Ferracane MJ, Olson LE. Impact of an over-the-counter "sleep lotion" on human salivary melatonin levels and sleep quality: a randomized controlled trial. Neuro Endocrinol Lett. 2024 Aug 12;45(3):167-172. |
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Anonymized participant data will be provided upon request
Starting after publication, and up to 10 years after publication
Will be provided to researchers affiliated with an academic institution upon request
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 9, 2026 | |
| Reset | Jun 4, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 9, 2026 | Jun 4, 2026 |
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.
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| Placebo control lotion | Other | 7 g of lotion applied to hands and arms one hour before bedtime |
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