The effect of CBD on sleep quality following late evening exercise

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Physiological processes [G07]

Trial duration

19 Mar 2026 → ongoing

Decision date (initial)

2026-01-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To investigate the effect of CBD on sleep efficiency (SE = time asleep (min) / time in bed (min)) following late evening exercise

Secondary objectives 5

1. To investigate the effect of CBD on other sleep indices including 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
2. to investigate the effect of CBD on perceived sleep quality via questionnaires
3. To investigate the effect of CBD on circulating hormones involved in sleep and stress (growth hormone, melatonin, cortisol)
4. To investigate the effect of CBD on plasma catecholamines (adrenaline, noradrenaline, dopamine) and serotonin concentration
5. To investigate the effect of CBD on urinary catecholamines (adrenaline, noradrenaline, dopamine) and serotonin excretion

Conditions and MedDRA coding

healthy individuals

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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; 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 30% (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 8

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
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))

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Changes in sleep efficiency between different sessions

Secondary endpoints 5

1. Changes in other sleep indices between different sessions
2. Changes in perceived sleep quality between different sessions
3. Changes in circulating hormones involved in sleep and stress between different sessions
4. Changes in plasma catecholamines and serotonin between different sessions
5. Changes urinary catecholamine and serotonin excretion between different sessions

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Katrien Koppo

Public contact point

Organisation

UZ Leuven

Contact name

Katrien Koppo

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications