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临床试验/NCT06053385
NCT06053385已完成不适用

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

University of Redlands2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
2
主要终点
Salivary melatonin

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 24 years old
  • current University of Redlands student

排除标准

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

结局指标

主要结局

Salivary melatonin

时间窗: 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

Sleep Quality

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa Olson

Professor of Biology

University of Redlands

研究点 (2)

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