INTERVENTIONALRECRUITINGNCT07570472

The Effect of CBD on Sleep Quality Following Late Evening Exercise

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-05-06

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 20 (ESTIMATED)
Start date: 2026-03-19
Sponsor: KU Leuven
Design: RANDOMIZED · CROSSOVER · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

cannabidiol

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Cannabidiol or placebo

participants receive 2 x 200mg CBD or placebo

BEHAVIORAL

late evening exercise

Participants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepted

Inclusion criteria

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. 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. 3. Age between 18-40 years old at the time of signing the Informed Consent Form (ICF) 4. Recreationally active (between 2-8h/wk) 5. Good health status confirmed by a sport medical screening 6. Body fat percentage below 20% (males) or 25% (females) as estimated by a Dual-energy X-ray absorptiometry (DXA) scan 7. Good sleep efficiency determined by the Pittsburgh Sleep Quality Index (PSQI, score ≤ 4)

Exclusion criteria

1. Self-reported sleep disturbances 2. Habitual smoking (\> 1 occasion/month) 3. Any kind of injury/incapability that is a contra-indication to perform high intensity interval training 4. 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. 5. Participation in another interventional Trial with an investigational medicinal product (IMP) or device 6. Use of CBD related products 3 months prior to the start of the experimental trial (including CBD oil, cannabis or other substances containing cannabinoids) 7. Intake of any medication or nutritional supplement that influences sleep quality 3 months prior to the start of the experimental trial 8. Shift workers or extreme morning and evening chronotypes (scores between 16-30 or 70-86 on the Morningness-Eveningness Questionnaire (MEQ))

primary outcomes

primary measures

sleep efficiency

Time frame: Nightly assessment on three specific study nights, separated by 7-day intervals

the primary outcome of the current study is the parameter sleep efficiency (SE = time asleep (min) / time in bed (min)) measured by PSG

secondary outcomes

secondary measures

Sleep indices (other than sleep efficiency)

Time frame: 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

Perceived sleep quality

Time frame: Assessment on three specific study mornings, separated by 7-day intervals

Participants complete the St. Mary's Hospital questionnaire to evaluate their subjective sleep quality from the previous night

Circulating hormones involved in sleep and stress

Time frame: Assessment on three specific study nights, separated by 7-day intervals

Circulating hormones such as growth hormone, melatonin and cortisol are measured

Plasma and urinary catecholamines (adrenaline, noradrenaline, dopamine) and serotonin concentration

Time frame: Assessment on three specific study nights, separated by 7-day intervals

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.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: eee04b15-6750-4864-bbac-7c9e5ce9e9a8
Retrieved: 24/09/2026, 14:14:19
SHA-256: 211307aa92aa5721e76a1598fad7c36a14a24593fa64e7cb4ad28d969d3832f2