NCT06053385

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

September 18, 2023

Last Update Submit

September 25, 2023

Conditions

Sleep

Keywords

melatoninlotion

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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).

Study Arms (2)

Melatonin sleep lotion Night 1; Placebo control lotion Night 2

EXPERIMENTAL

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 lotionOther: Placebo control lotion

Placebo control lotion Night 1; Melatonin sleep lotion Night 2

EXPERIMENTAL

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 lotionOther: Placebo control lotion

Interventions

Melatonin sleep lotionOTHER

7 g of lotion applied to hands and arms one hour before bedtime

Also known as: Dr. Teal's Sleep Lotion
Melatonin sleep lotion Night 1; Placebo control lotion Night 2Placebo control lotion Night 1; Melatonin sleep lotion Night 2
Placebo control lotionOTHER

7 g of lotion applied to hands and arms one hour before bedtime

Also known as: Dr. Teal's Lavender Essential Oils Lotion
Melatonin sleep lotion Night 1; Placebo control lotion Night 2Placebo control lotion Night 1; Melatonin sleep lotion Night 2

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 24 years old
  • current University of Redlands student

You may not qualify if:

  • Pregnancy
  • currently taking any sleep medications
  • allergies or sensitivities to scented lotion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Redlands

Redlands, California, 92373, United States

Location

Related Publications (1)

  • Ponce C, Razon AD, Chao J, Nakagawa SK, Peterson MM, Roque AY, Vanderpool MA, Ferracane MJ, Olson LE. Impact of an over-the-counter "sleep lotion" on human salivary melatonin levels and sleep quality: a randomized controlled trial. Neuro Endocrinol Lett. 2024 Aug 12;45(3):167-172.

    PMID: 39146562DERIVED

Study Officials

  • Lisa Olson, Ph.D.

    University of Redlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biology

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 25, 2023

Study Start

February 9, 2022

Primary Completion

March 8, 2023

Study Completion

April 20, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Anonymized participant data will be provided upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Starting after publication, and up to 10 years after publication
Access Criteria
Will be provided to researchers affiliated with an academic institution upon request

Locations

US(1)