Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Qualia Sleep Formula A (Dietary Supplement)
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.
干预措施: Qualia Sleep Formula B (Dietary Supplement)
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.
干预措施: Qualia Sleep Formula D (Dietary Supplement)
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.
干预措施: Qualia Sleep Formula C (Dietary Supplement)
结局指标
主要结局
Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score
时间窗: 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.
次要结局
- Change from baseline in PROMIS Sleep Disturbance (PROMIS-SD) score in the higher-disturbance subgroup(Baseline to Day 28)
- Change from baseline in PROMIS Sleep-Related Impairment v1.0 Short Form 8a (PROMIS-SRI) score(Baseline to Day 28)
- Change from baseline in Pre-Sleep Arousal Scale (PSAS) somatic and cognitive arousal scores(Baseline to Day 28)
- Safety and tolerability profile(Days 1, 3, 7, 14, 21, and 28)