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Идёт набор NCT07311434

Sleep and Morning Wellbeing Study

Без фазы С лечением Sleep Relaxation Stress Daytime Sleepiness

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: Sleep Supplement.
Кому может быть актуально
Состояния в реестре: Sleep, Relaxation, Stress, Daytime Sleepiness. Базовые параметры: 22 лет — 59 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
США
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

Evaluation of Perceived Outcomes With AGZ: A Randomized, Controlled, Consumer Perception Study

Обзор

The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 30 days. The subjects will complete questionnaires throughout the study at pre-specified timepoints.

Вмешательства

  • Пищевая добавка Sleep Supplement
    Powdered sleep supplement

Первичные конечные точки

  • Evening relaxation, sleep quality, and morning vitality [Срок оценки: Days 1, 3, 7, 14, 30]

Критерии участия

Критерии включения

  • Male or female.
  • Age 25-59 years.
  • BMI ≥18.5 and ≤29.9 kg/m².
  • Currently experiencing issues with sleep quality, falling asleep, staying asleep, or waking during the night.
  • RU-SATED score ≤17.
  • Willing and able to follow the study protocol.
  • Willing to discontinue any other supplements (including nootropics, adaptogens, calming herbs), medications, herbal remedies, or over-the-counter sleep medications (e.g., zolpidem, diphenhydramine, Benadryl, ZzzQuil, Unisom, magnesium or melatonin products) used to assist with sleep during the study.
  • Agree to limit alcohol intake within approximately 4 hours of bedtime throughout participation.
  • Agree to limit caffeine intake to ≤400 mg/day (about 3-4 cups of coffee) and avoid ingestion of caffeine-containing products after 2:00 PM during the study period.
  • Generally healthy and not living with any uncontrolled chronic disease.
  • Resides in the United States.
  • Willing to discontinue any restricted products and adhere to all required study assessments.

Критерии исключения

  • Diagnosed chronic sleep conditions (e.g., insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome, sleep apnea).
  • Current use of sleep-tracking technology (e.g., wrist-worn trackers, rings, smartphone apps) that could influence sleep behavior or perception.

Women currently undergoing perimenopause or experiencing vasomotor symptoms (e.g., night sweats).

  • Use of hormone therapy (estrogen, progesterone, phytoestrogens) within the last 3 months.
  • Diagnosed psychiatric disorders including major depressive disorder with acute symptoms, bipolar disorder, generalized anxiety disorder with active symptoms, and PTSD with frequent nightmares.
  • Diagnosed neurodegenerative or chronic pain disorders, including Parkinson's disease, Alzheimer's disease, or uncontrolled fibromyalgia.
  • Regular prescribed stimulant use (e.g., amphetamines such as Adderall/Vyvanse; methylphenidate such as Ritalin/Concerta; modafinil/armodafinil).
  • Current use of CNS-activating antidepressants (bupropion, fluoxetine, venlafaxine, sertraline).
  • Current or recent use of cannabis or THC-containing products (recreational or medicinal marijuana, CBD with measurable THC, synthetic cannabinoids) within the past 30 days.
  • Employment in jobs disrupting nighttime sleep (e.g., night shift, rotating shift, excessive travel).
  • Current use of prescription sleep aids.
  • Introduction of any new sleep-related supplements, medications, herbal remedies, or melatonin products during the study.
  • Use of any prescription or OTC products with sedative properties (e.g., melatonin, diphenhydramine, doxylamine, valerian, ZzzQuil, Advil PM) within 4 weeks prior to enrollment or habitual use ≥3 times per week prior to enrollment unless investigator-approved.
  • Allergy or sensitivity to any study product ingredients.
  • Pregnant, breastfeeding, or trying to conceive during the study period.
  • History of substance abuse.
  • Heavy alcohol use (≥8 drinks/week for women or ≥15 drinks/week for men).
  • Participation in another research study now or within the next 7 weeks.
  • Any condition or behavior that, in the investigator's judgment, may interfere with study participation or data integrity.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Alethios (Virtual Study Platform) — San Francisco

Идентификаторы

NCT: NCT07311434 · AGZ001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗