A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Asutra
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Changes in "sleep score" given by wearable sleep tracker. [Timeline: Baseline to Week 3]
研究概览
简要总结
This study will evaluate the efficacy of Asutra's 'Dream the night away' nighttime lotion with melatonin and magnesium on sleep health in terms of quantity, quality, ease of falling asleep or falling back asleep after waking in the night, and grogginess upon waking. The study will be conducted as a virtual single-group trial in which all 35 participants will use the test product. This study will last 3 weeks, and participants will use the product daily (each night 30 minutes before bedtime for 20 nights). Participants will use a sleep tracker to monitor their sleep for a week at Baseline (before commencing the trial) and nightly throughout the trial. Participants will complete study-specific questionnaires at Baseline, and after first use, 3 days, 1 week, 2 weeks, and 3 weeks, in which they will also record the results from their sleep tracker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18-
- •Must agree to not use any other sleep aids including prescriptions, supplements, or melatonin products during the study or 28 days prior to Baseline.
- •Has favorable sleep conditions (a dark, quiet room to sleep in and is not woken up regularly throughout the night due to personal circumstances e.g. by a baby).
- •Willing to maintain their standard sleep pattern and activity level for the duration of the study.
- •Be generally healthy and not living with any uncontrolled chronic disease. Willing and able to supply and use their own sleep tracking device.
排除标准
- •Diagnosed with any chronic sleep condition including insomnia, narcolepsy, or sleep apnea.
- •Has extremely sensitive/irritable skin or diagnosed skin conditions.
- •Has poor sleep hygiene as a result of specific personal circumstances e.g. new mothers.
- •Women who are pregnant, breastfeeding, or attempting to become pregnant.
- •Anyone unwilling or unable to follow the study protocol.
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- •Is currently undergoing, or planning to to undergo any sleep-related procedures in the next three weeks.
- •A history of severe allergic reactions including but not limited to any of the product's ingredients.
- •Heavy drinkers or drug users. A heavy drinker is considered to be a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week.
结局指标
主要结局
Changes in "sleep score" given by wearable sleep tracker. [Timeline: Baseline to Week 3]
时间窗: 3 weeks
The Fitbit Inspire 3 gives a nightly "sleep score". This is based on heart rate, the time spent awake or restless, and the sleep stages. The score is out of 100, with 100 being the best possible score.
Changes in time asleep recorded by a wearable sleep tracker. [Timeline: Baseline to Week 3]
时间窗: 3 weeks
The total time asleep every night will be recorded using a wearable sleep tracker, the Fitbit Inspire 3.
Changes in scores on the validated Sleep Quality Scale (SQS). [Timeline: Baseline to Week 3]
时间窗: 3 weeks
Consisting of 28 items, the SQS evaluates six domains of sleep quality: daytime symptoms, restoration after sleep, problems initiating. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "some- times," 2 = "often," and 3 = "almost always").
次要结局
- Participants' perceptions of the product's efficacy. [Timeline: Baseline to Week 3](3 weeks)