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Идёт набор NCT07570472

The Effect of CBD on Sleep Quality Following Late Evening Exercise

Фаза II С лечением Sleep Quality

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: Cannabidiol or placebo, late evening exercise.
Кому может быть актуально
Состояния в реестре: Sleep Quality. Базовые параметры: 18 лет — 40 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
Бельгия
Следующий шаг
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Обзор

The trial is a double-blind, placebo-controlled crossover design. In a randomized order, 20 participants undergo one control and two experimental sessions separated by a 1-week wash out period. During the no exercise/rest session, participants' sleep is monitored via polysomnography following a rest day. During the training sessions participants' sleep is monitored following a high intensity interval training (HIIT) in the late evening (finishing 1h prior to bedtime). During these sessions participants receive 2x 200mg CBD or placebo in a randomized order.

Вмешательства

  • Препарат Cannabidiol or placebo
    participants receive 2 x 200mg CBD or placebo
  • Поведенческое late evening exercise
    Participants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep

Первичные конечные точки

  • sleep efficiency [Срок оценки: Nightly assessment on three specific study nights, separated by 7-day intervals]
Вторичные конечные точки (4)
  • Sleep indices (other than sleep efficiency) [Срок оценки: Nightly assessment on three specific study nights, separated by 7-day intervals]
  • Perceived sleep quality [Срок оценки: Assessment on three specific study mornings, separated by 7-day intervals]
  • Circulating hormones involved in sleep and stress [Срок оценки: Assessment on three specific study nights, separated by 7-day intervals]
  • Plasma and urinary catecholamines (adrenaline, noradrenaline, dopamine) and serotonin concentration [Срок оценки: Assessment on three specific study nights, separated by 7-day intervals]

Критерии участия

Критерии включения

  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • Use of highly effective methods of birth control during the entire trial and for up to 4 months after the last dose of CBD; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
  • Age between 18-40 years old at the time of signing the Informed Consent Form (ICF)
  • Recreationally active (between 2-8h/wk)
  • Good health status confirmed by a sport medical screening
  • Body fat percentage below 20% (males) or 25% (females) as estimated by a Dual-energy X-ray absorptiometry (DXA) scan
  • Good sleep efficiency determined by the Pittsburgh Sleep Quality Index (PSQI, score ≤ 4)

Критерии исключения

  • Self-reported sleep disturbances
  • Habitual smoking (> 1 occasion/month)
  • Any kind of injury/incapability that is a contra-indication to perform high intensity interval training
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
  • Participation in another interventional Trial with an investigational medicinal product (IMP) or device
  • Use of CBD related products 3 months prior to the start of the experimental trial (including CBD oil, cannabis or other substances containing cannabinoids)
  • Intake of any medication or nutritional supplement that influences sleep quality 3 months prior to the start of the experimental trial
  • Shift workers or extreme morning and evening chronotypes (scores between 16-30 or 70-86 on the Morningness-Eveningness Questionnaire (MEQ))

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Бельгия · 1 центр
  • Bakala Athletic Performance Facility — Leuven

Идентификаторы

NCT: NCT07570472 · S69706 · 2024-518609-17-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗