Cheers Health Restore Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Sleep Quality
研究概览
简要总结
This observational cohort study, sponsored by Cheers Health and conducted by Principal Investigator Dr. Nirav Shah, aims to evaluate the potential role of Cheers Restore in supporting sleep quality, physiological recovery, and next-day well-being following alcohol consumption in healthy adults. Over a 6 week period, the study will utilize wearable devices and self-reported outcomes captured via the Alethios platform to assess real-world responses to use of Cheers Restore. Outcomes will be compared across three behavioral conditions: (1) alcohol consumption followed by Cheers Restore use, (2) alcohol-only nights without use of Cheers Restore, and (3) non-drinking nights.
详细描述
Alcohol consumption is known to reduce REM sleep, impair heart rate variability (HRV), and increase next-day fatigue, irritability, and cognitive disruption. Moderate alcohol intake can disrupt circadian rhythm and impair autonomic recovery. Prior research has shown dietary supplements containing amino acids, antioxidants, and electrolytes may support recovery, but few studies have assessed real-world behavioral patterns using digital health technology. Observational data from wearable devices and participant-reported outcomes can offer scalable, ecologically valid insights into how lifestyle products may mitigate alcohol-induced disruption.
Cheers Restore contains a formulation of antioxidants, electrolytes, and plant-based compounds designed to support physiological resilience and sleep recovery after alcohol consumption. This study is structured to evaluate Cheers Restore in a real-world setting without introducing investigational or therapeutic claims. By capturing participant-driven usage patterns and outcomes, the study enables ecological validation and supports responsible product communication aligned with DSHEA and FTC guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 21 years or older
- •Regular alcohol consumers (defined as ≥1 drinking night per week)
- •Ownership of and willingness to use a wearable device compatible with the Alethios platform (e.g., Fitbit, Apple Watch, Oura)
- •Ability and willingness to log alcohol consumption, Cheers Restore usage, and complete daily and weekly surveys via smartphone or web
- •Willingness to use Cheers Restore during the study period when consuming alcohol
- •English-speaking, capable of understanding informed consent
排除标准
- •AUDIT-C score above gender-specific thresholds for hazardous drinking (≥4 for men, ≥3 for women)
- •History of alcohol use disorder or prior treatment for substance misuse
- •Routine binge drinking (≥5 drinks/occasion for men, ≥4 for women)
- •Use of confounding substances:
- •THC (any form)
- •Recreational drugs
- •Prescription stimulants, sedatives, or sleep aids
- •Diagnosed sleep or psychiatric conditions known to impair sleep quality (e.g., insomnia, obstructive sleep apnea, restless legs syndrome, narcolepsy, major depressive disorder, post-traumatic stress disorder, bipolar disorder, schizophrenia, attention deficit/hyperactivity disorder)
- •Pregnancy or breastfeeding
- •Anticipated travel or scheduling conflicts disrupting normal sleep/alcohol routines
- •Inability to comply with platform-based data collection requirements
结局指标
主要结局
Sleep Quality
时间窗: 6 weeks
Sleep quality, as measured by wearables such as Fitbit, Garmin and Oura rings (time spent in sleep stages, wakeup events, sleep onset).
次要结局
- Alcohol Consumption Behavior(6 weeks)
- Heart Rate Variability(6 weeks)