The Effect of CBD on Sleep Quality Following Late Evening Exercise
2026年4月30日 更新者:KU Leuven
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.
研究概览
研究类型
介入性
注册 (估计的)
20
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Vlaams-Brabant
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Leuven、Vlaams-Brabant、比利时、3001
- 招聘中
- Bakala Athletic Performance Facility
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接触:
- Prof. Koppo
- 电话号码:+32 16 37 26 80
- 邮箱:katrien.koppo@kuleuven.be
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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))
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Exercise session 1
Participants perform a late evening exercise and receive placebo/CBD supplements
|
participants receive 2 x 200mg CBD or placebo
Participants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep
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|
实验性的:Exercise session 2
Participants perform a late evening exercise and receive placebo/CBD supplements
|
participants receive 2 x 200mg CBD or placebo
Participants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep
|
|
实验性的:No exercise / rest session
Participants do not perform a late evening exercise and receive placebo/CBD supplements
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participants receive 2 x 200mg CBD or placebo
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
sleep efficiency
大体时间:Nightly assessment on three specific study nights, separated by 7-day intervals
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the primary outcome of the current study is the parameter sleep efficiency (SE = time asleep (min) / time in bed (min)) measured by PSG
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Nightly assessment on three specific study nights, separated by 7-day intervals
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sleep indices (other than sleep efficiency)
大体时间:Nightly assessment on three specific study nights, separated by 7-day intervals
|
These outcomes include sleep period time (SPT), wake after sleep onset (WASO), total sleep time (TST), sleep onset latency (SOL), sleep maintenance efficiency (SME), amount of time in sleep stages (N1, N2, N3, REM, NREM), slow waves, sleep spindles
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Nightly assessment on three specific study nights, separated by 7-day intervals
|
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Perceived sleep quality
大体时间:Assessment on three specific study mornings, separated by 7-day intervals
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Participants complete the St. Mary's Hospital questionnaire to evaluate their subjective sleep quality from the previous night
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Assessment on three specific study mornings, separated by 7-day intervals
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Circulating hormones involved in sleep and stress
大体时间:Assessment on three specific study nights, separated by 7-day intervals
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Circulating hormones such as growth hormone, melatonin and cortisol are measured
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Assessment on three specific study nights, separated by 7-day intervals
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|
Plasma and urinary catecholamines (adrenaline, noradrenaline, dopamine) and serotonin concentration
大体时间:Assessment on three specific study nights, separated by 7-day intervals
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Plasma catecholamines (adrenaline, noradrenaline, dopamine) and serotonin concentration is measured in blood samples collected 30 minutes prior to sleep, and in urine samples collected during the night.
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Assessment on three specific study nights, separated by 7-day intervals
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年3月19日
初级完成 (估计的)
2026年5月31日
研究完成 (估计的)
2026年6月7日
研究注册日期
首次提交
2026年4月30日
首先提交符合 QC 标准的
2026年4月30日
首次发布 (实际的)
2026年5月6日
研究记录更新
最后更新发布 (实际的)
2026年5月6日
上次提交的符合 QC 标准的更新
2026年4月30日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.