Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06053385
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2023-09-18
Brief Title:
Impact of Commercial Sleep Lotion on Salivary Melatonin Levels and Sleep Quality in Undergraduates
Sponsor:
University of Redlands
Organization:
University of Redlands
Study Overview
Official Title:
Impact of Commercial Sleep Lotion on Salivary Melatonin Levels and Sleep Quality in Undergraduates
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None