Clinical trial NCT06053385: Impact of Commercial "Sleep Lotion" on Salivary Melatonin Levels and Sleep Quality in Undergraduates
Official title: Impact of Commercial "Sleep Lotion" on Salivary Melatonin Levels and Sleep Quality in Undergraduates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: melatonin
lotion
Lead sponsor: University of Redlands
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Salivary melatonin
timeFrame: 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.
measure: Sleep Quality
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Redlands
country: United States
facility: University of Redlands
state: California
Study officials:
affiliation: University of Redlands
name: Lisa Olson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: