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

September 25, 2023 updated by: Lisa Olson, University of Redlands

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Redlands, California, United States, 92373
        • University of Redlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin sleep lotion Night 1; Placebo control lotion Night 2
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.
Other: Melatonin sleep lotion
7 g of lotion applied to hands and arms one hour before bedtime
Other Names:
  • Dr. Teal's Sleep Lotion
Other: Placebo control lotion
7 g of lotion applied to hands and arms one hour before bedtime
Other Names:
  • Dr. Teal's Lavender Essential Oils Lotion
Experimental: Placebo control lotion Night 1; Melatonin sleep lotion Night 2
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."
Other: Melatonin sleep lotion
7 g of lotion applied to hands and arms one hour before bedtime
Other Names:
  • Dr. Teal's Sleep Lotion
Other: Placebo control lotion
7 g of lotion applied to hands and arms one hour before bedtime
Other Names:
  • Dr. Teal's Lavender Essential Oils Lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary melatonin
Time Frame: 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.
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
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Redlands

Investigators

  • Principal Investigator: Lisa Olson, Ph.D., University of Redlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2022

Primary Completion (Actual)

March 8, 2023

Study Completion (Actual)

April 20, 2023

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-37-REDLANDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized participant data will be provided upon request

IPD Sharing Time Frame

Starting after publication, and up to 10 years after publication

IPD Sharing Access Criteria

Will be provided to researchers affiliated with an academic institution upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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