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Набор скоро начнётся NCT07069608

Cheers Health Restore Study

— Наблюдательное Sleep Alcohol Aftereffects Recovery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cheers Restore.
Кому может быть актуально
Состояния в реестре: Sleep, Alcohol Aftereffects, Recovery. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Cheers Health Restore Observational Study

Обзор

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.

Подробное описание

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.

Вмешательства

  • Пищевая добавка Cheers Restore
    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.

Первичные конечные точки

  • Sleep Quality [Срок оценки: 6 weeks]
Вторичные конечные точки (2)
  • Alcohol Consumption Behavior [Срок оценки: 6 weeks]
  • Heart Rate Variability [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07069608 · 1002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗