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

University of Redlands

Status: Completed

Conditions: Sleep

Treatments: Other: Melatonin sleep lotion; Other: Placebo control lotion

Study type: Interventional

Funder types: Other

Identifiers

NCT06053385

2021-37-REDLANDS

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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63 participants in 2 patient groups

Melatonin sleep lotion Night 1; Placebo control lotion Night 2

Experimental group

Description:

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.

Treatment:

Other: Placebo control lotion

Other: Melatonin sleep lotion

Placebo control lotion Night 1; Melatonin sleep lotion Night 2

Experimental group

Description:

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."

Treatment:

Other: Placebo control lotion

Other: Melatonin sleep lotion