Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
2026年8月10日 更新者：Qualia Life Sciences
This is a randomized, open-label, 4-arm pilot study designed to evaluate the efficacy and tolerability of four Qualia Sleep formulations (Formulas A, B, C, and D) in healthy adults aged 18 years and older who report poor sleep quality.
The investigational products are encapsulated dietary supplements intended to support sleep quality and satisfaction.
Approximately 100 participants will be allocated to one of four arms (n≈25 per arm) and will take 2 capsules of their assigned Qualia Sleep formula once daily for 28 consecutive days, administered 30-60 minutes before bedtime.
The primary objective is to assess changes in sleep quality and satisfaction from baseline to Day 28 using the PROMIS Sleep Disturbance - Short Form 8b, with secondary outcomes including sleep-related impairment, pre-sleep arousal, and overall safety and tolerability.
All study data, including self-reported sleep and safety questionnaires, will be collected electronically via secure links; there are no in-person visits or clinic-based assessments.
研究概览
地位
尚未招聘
条件
详细说明
The primary aim of this open-label, four-arm pilot study is to evaluate the efficacy of four Qualia Sleep formulations (A, B, C, and D) in improving sleep quality and satisfaction over 28 days in adults reporting sleep disturbances, as assessed by the PROMIS Sleep Disturbance - Short Form 8b (PROMIS-SD).
The primary objective is to determine the change from baseline to day 28 in PROMIS-SD scores across all participants using each formulation.
Secondary objectives are to: (1) assess changes in PROMIS-SD in a subgroup with more pronounced baseline sleep disturbance; (2) evaluate changes in sleep-related daytime impairment using the PROMIS Sleep-Related Impairment Short Form 8a (PROMIS-SRI) in both the overall sample and the higher-disturbance subgroup; (3) examine changes in somatic and cognitive pre-sleep arousal as measured by the Pre-Sleep Arousal Scale (PSAS) in both the overall sample and the higher-disturbance subgroup; and (4) characterize the safety and tolerability profile of each formulation over the 28-day supplementation period.
Participants take 2 capsules once daily at night, 30-60 minutes before bed, for 28 consecutive days.
Participants complete regular check-in surveys on days 1, 3, 7, 14, 21, and 28.
All study data will be collected electronically using secure survey links completed remotely on participants' own devices.
研究类型
介入性
注册 (估计的)
100
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。
学习联系方式
- 姓名：William Director of Research
- 电话号码：855-281-2328
- 邮箱：science@qualialife.com
研究联系人备份
- 姓名：Abhimanyu Study coordinator
- 电话号码：855-281-2328
- 邮箱：science@qualialife.com
学习地点
-
-
California
-
Carlsbad、California、美国、92008
- Qualia Life Sciences
-
-
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
- 年长者
接受健康志愿者
是的
描述
Inclusion criteria:
- Healthy female and male adults aged 18 years and older with poor sleep quality.
- A raw score ≥25 on the PROMIS Sleep Disturbance - Short Form questionnaire (preference given to participants with a higher score).
- Can read and write English.
- Provide voluntary, written, informed consent to participate in the study.
- Agree to provide a valid cell phone number and are willing to receive communications through text.
- Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly.
- Willing to complete questionnaires, records, and diaries associated with the study.
Exclusion criteria:
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
- Known food intolerances/allergy to any ingredients in the product.
- Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer.
- Having had a significant cardiovascular event in the past 6 months.
- Taking any of the following medications, or on immunosuppressive therapy:
- Psychiatric or neurological medications - including antidepressants (e.g., MAO inhibitors, SSRIs) and anxiolytics
- Sleep medications - sedatives, hypnotics, benzodiazepines, dual orexin receptor antagonists, melatonin receptor agonists
- Individuals who were deemed incompatible with the test protocol.
- Adults lacking capacity to consent.
- Unable to read and understand English.
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：其他
- 分配：随机化
- 介入模型：并行分配
- 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：Qualia Sleep Formula A
Participants take Qualia Sleep Formula A capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
|
Oral Capsules.
Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
|
|
实验性的：Qualia Sleep Formula B
Participants take Qualia Sleep Formula B capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
|
Oral capsules.
Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
|
|
实验性的：Qualia Sleep Formula C
Participants take Qualia Sleep Formula C capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
|
Oral capsules.
Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
|
|
实验性的：Qualia Sleep Formula D
Participants take Qualia Sleep Formula D capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
|
Oral capsules.
Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
|
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 from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score
大体时间：Baseline to Day 28
|
Change from baseline to day 28 in PROMIS-SD scores across all participants using each formulation.
The 8-item questionnaire assesses self-reported perceptions of sleep quality, sleep depth and restoration, and difficulties and dissatisfaction with sleep during the past 7 days.
Total raw score ranges from 8 to 40, with higher scores indicating greater sleep disturbance.
|
Baseline to Day 28
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in PROMIS Sleep Disturbance (PROMIS-SD) score in the higher-disturbance subgroup
大体时间：Baseline to Day 28
|
Change in PROMIS-SD in a subgroup with more pronounced baseline sleep disturbance.
|
Baseline to Day 28
|
|
Change from baseline in PROMIS Sleep-Related Impairment v1.0 Short Form 8a (PROMIS-SRI) score
大体时间：Baseline to Day 28
|
Changes in sleep-related daytime impairment using the PROMIS-SRI in both the overall sample and the higher-disturbance subgroup.
The 8-item questionnaire assesses daytime consequences of poor sleep.
Total raw score ranges from 8 to 40, with higher scores indicating greater sleep-related impairment.
|
Baseline to Day 28
|
|
Change from baseline in Pre-Sleep Arousal Scale (PSAS) somatic and cognitive arousal scores
大体时间：Baseline to Day 28
|
Changes in somatic and cognitive pre-sleep arousal as measured by the PSAS in both the overall sample and the higher-disturbance subgroup.
Two subscales (somatic items 1-8, cognitive items 9-16), each scoring 8-40, with higher scores indicating greater pre-sleep arousal.
|
Baseline to Day 28
|
|
Safety and tolerability profile
大体时间：Days 1, 3, 7, 14, 21, and 28
|
Characterize the safety and tolerability profile of each formulation over the 28-day supplementation period using the Safety and Tolerability Questionnaire assessing symptoms including increased anxiety/worry, headache, mood changes, stomach upset/nausea, dizziness, bloating, itching, and sexual dysfunction.
Higher score = worsening of symptoms.
|
Days 1, 3, 7, 14, 21, and 28
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Follow-Up Questionnaire (overall product experience and rating)
大体时间：5-7 days after final dose
|
Overall experience of the product, product rating, and purchase interest.
Success criteria for the test product is at least 80% excellent + good ratings on the overall experience question, with more than 25% of all ratings being excellent.
|
5-7 days after final dose
|
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。
调查人员
- 首席研究员：William Director of Research、Qualia Life Sciences
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 (估计的)
2026年8月28日
初级完成 (估计的)
2026年10月31日
研究完成 (估计的)
2026年10月31日
研究注册日期
首次提交
2026年7月29日
首先提交符合 QC 标准的
2026年7月29日
首次发布 (实际的)
2026年8月4日
研究记录更新
最后更新发布 (实际的)
2026年8月12日
上次提交的符合 QC 标准的更新
2026年8月10日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- QLS-024
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.