NCT06053385

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: University of Redlands · Academic / Other
• Sex: All
• Age: 18 Years – 24 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep

Interventions

Type	Name	Description
OTHER	Melatonin sleep lotion	7 g of lotion applied to hands and arms one hour before bedtime
OTHER	Placebo control lotion	7 g of lotion applied to hands and arms one hour before bedtime

Timeline

• Start date: 2022-02-09
• Primary completion: 2023-03-08
• Completion: 2023-04-20
• First posted: 2023-09-25
• Last updated: 2023-09-28

Locations

1 site across 1 country: United States