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

Sponsor
University of Redlands (Other)
Overall Status
Completed
CT.gov ID
NCT06053385
Collaborator
(none)
63
Enrollment
1
Location
2
Arms
14.3
Actual Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Melatonin sleep lotion
  • Other: Placebo control lotion
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Impact of Commercial "Sleep Lotion" on Salivary Melatonin Levels and Sleep Quality in Undergraduates
Actual Study Start Date :
Feb 9, 2022
Actual Primary Completion Date :
Mar 8, 2023
Actual Study Completion Date :
Apr 20, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Salivary melatonin [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

    2. 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).]

      Modified Pittsburgh Sleep Quality Index. Scores from 0 (good sleep quality) to 14 (poor sleep quality)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 24 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Redlands Redlands California United States 92373

    Sponsors and Collaborators

    • University of Redlands

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lisa Olson, Professor of Biology, University of Redlands
    ClinicalTrials.gov Identifier:
    NCT06053385
    Other Study ID Numbers:
    • 2021-37-REDLANDS
    First Posted:
    Sep 25, 2023
    Last Update Posted:
    Sep 28, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lisa Olson, Professor of Biology, University of Redlands
    melatonin
    lotion
    Additional relevant MeSH terms:
    Melatonin

    Study Results

    No Results Posted as of Sep 28, 2023