A Clinical Trial to Evaluate the Effects of a Topical Roll-on and Diffuser Blend on Sleep Quality and Sleep Duration
2026年8月19日 更新者：Saie Beauty
This study will evaluate the effects of the Saje Sleep Well topical roll-on and the Saje Sleep Well diffuser blend on sleep quality and sleep duration in adults who have experienced issues with sleep quality and sleep duration over the past four weeks. The trial involves 40 participants and is conducted over seven weeks in total, including a one-week Fitbit calibration period and a six-week study intervention.
During Weeks 1-3, participants will use the Sleep Well Diffuser Blend nightly. During Weeks 4-6, participants will switch to the Sleep Well Roll-On, applied to the wrists, throat, and temples one hour before bedtime. Sleep measurements will be collected via Fitbit device and self-reported questionnaires, including the validated Sleep Quality Score (SQS), at Baseline and at the end of Weeks 2, 3, 5, and 6.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Nevada
-
Las Vegas、Nevada、美国、89101
- Citruslabs
-
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Adults aged 18-60
- Anyone who has experienced issues regarding sleep quality over the past four weeks
- Anyone who has experienced issues regarding sleep duration over the past four weeks
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease
- If taking oral over-the-counter supplements or herbal remedies targeted at sleep quality and sleep duration, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration
- Willing to refrain from introducing any products or any new forms of prescription medication or supplements that target sleep quality and sleep duration for the study duration
- Resides in the United States
- Anyone willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial
Exclusion Criteria:
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Anyone diagnosed with a sleep disorder or taking prescription medications for sleep
- Anyone who is involved with shift work
- Anyone with any allergies or sensitivities to any of the study product ingredients
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
- Anyone unwilling to follow the study protocol
- Anyone who identifies as having sensitive skin
- Anyone with a history of skin cancer or any pre-cancerous lesions on their skin
- Anyone with a history of substance abuse or heavy alcohol use (more than 14 drinks per week)
- Anyone who is currently a smoker or has been a smoker in the past 3 months
- Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration
- Anyone with chronic skin conditions (e.g., dermatitis, eczema, psoriasis)
- Anyone who has epilepsy
- Anyone with asthma, COPD, or significant respiratory conditions
- Anyone who suffers from migraines or headaches that are triggered or worsened by smells, perfumes, essential oils, or fragranced products
- Anyone with hypertension or taking antihypertensive medications
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sleep Well Diffuser Blend followed by Sleep Well Roll-On
|
All participants use the Sleep Well Diffuser Blend during Weeks 1-3 (20 drops added to diffuser on intermittent mode, one hour before bedtime, run throughout the night), then switch to the Sleep Well Roll-On during Weeks 4-6 (applied to wrists, throat, and temples once daily, one hour before bedtime)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Sleep Quality as Assessed by Sleep Quality Score (SQS)
大体时间：Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in Sleep Quality Score (SQS), as assessed by the validated SQS questionnaire.
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Baseline, Week 2, Week 3, Week 5, Week 6
|
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Change in Sleep Duration as Assessed by Fitbit Sleep Duration
大体时间：Baseline, Week 2, Week 3, Week 5, Week 6
|
Change from baseline in sleep duration measured by the participant's Fitbit device.
Sleep duration will be summarized at each assessment time point.
|
Baseline, Week 2, Week 3, Week 5, Week 6
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Participant-Perceived Change in Sleep Quality
大体时间：Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in participant-reported sleep quality, as assessed by the study self-reported questionnaire.
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Baseline, Week 2, Week 3, Week 5, Week 6
|
|
Participant-Perceived Change in Sleep Duration
大体时间：Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in participant-reported sleep duration, as assessed by the study self-reported questionnaire.
|
Baseline, Week 2, Week 3, Week 5, Week 6
|
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Participant-Perceived Change in Fatigue
大体时间：Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in participant-reported fatigue, as assessed by the study self-reported questionnaire.
|
Baseline, Week 2, Week 3, Week 5, Week 6
|
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Participant-Perceived Change in Energy Levels
大体时间：Baseline, Week 2, Week 3, Week 5, Week 6
|
Change from baseline in participant-reported energy levels, as assessed by the study self-reported questionnaire.
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Baseline, Week 2, Week 3, Week 5, Week 6
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Participant-Perceived Change in Overall Health
大体时间：Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in participant-reported overall health and well-being, as assessed by the study self-reported questionnaire.
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Baseline, Week 2, Week 3, Week 5, Week 6
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
合作者
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月1日
初级完成 (实际的)
2026年6月1日
研究完成 (实际的)
2026年6月1日
研究注册日期
首次提交
2026年8月11日
首先提交符合 QC 标准的
2026年8月19日
首次发布 (实际的)
2026年8月21日
研究记录更新
最后更新发布 (实际的)
2026年8月21日
上次提交的符合 QC 标准的更新
2026年8月19日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.