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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06053385
• Other study ID #: 2021-37-REDLANDS
• Status: Completed
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: September 2023
• Source: University of Redlands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 20, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Other:
• Melatonin sleep lotion
7 g of lotion applied to hands and arms one hour before bedtime
• Placebo control lotion
7 g of lotion applied to hands and arms one hour before bedtime

Locations

Country	Name	City	State
United States	University of Redlands	Redlands	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Redlands

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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).