Sleep QualityPhase 2NCT07570472
The Effect of CBD on Sleep Quality Following Late Evening Exercise
A Phase 2 study testing late evening exercise in people with Sleep Quality, run by KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- late evening exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Mar 2026to 7 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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))
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Bakala Athletic Performance Facility
Leuven, Vlaams-Brabant, 3001
Prof. Koppo, +32 16 37 26 80, katrien.koppo@kuleuven.be
About this study
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.
- Conditions
- Sleep Quality
- Being tested
- Cannabidiol or placebo, late evening exercise
- Keywords
- Cannabidiol, Sleep quality, Late evening exercise, Polysomnography
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol or placeboDrug
participants receive 2 x 200mg CBD or placebo
late evening exerciseBehavioural
Participants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep
| Study group | Role | What they receive |
|---|---|---|
| Exercise session 1 | Experimental | Participants perform a late evening exercise and receive placebo/CBD supplements Receives: Drug: Cannabidiol or placebo; Behavioral: late evening exercise |
| Exercise session 2 | Experimental | Participants perform a late evening exercise and receive placebo/CBD supplements Receives: Drug: Cannabidiol or placebo; Behavioral: late evening exercise |
| No exercise / rest session | Experimental | Participants do not perform a late evening exercise and receive placebo/CBD supplements Receives: Drug: Cannabidiol or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep efficiency
the primary outcome of the current study is the parameter sleep efficiency (SE = time asleep (min) / time in bed (min)) measured by PSG
Measured: Nightly assessment on three specific study nights, separated by 7-day intervals
Secondary outcomes (4)
Sleep indices (other than sleep efficiency)
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
Measured: Nightly assessment on three specific study nights, separated by 7-day intervals
Perceived sleep quality
Participants complete the St. Mary's Hospital questionnaire to evaluate their subjective sleep quality from the previous night
Measured: Assessment on three specific study mornings, separated by 7-day intervals
Circulating hormones involved in sleep and stress
Circulating hormones such as growth hormone, melatonin and cortisol are measured
Measured: Assessment on three specific study nights, separated by 7-day intervals
Plasma and urinary catecholamines (adrenaline, noradrenaline, dopamine) and serotonin concentration
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.
Measured: Assessment on three specific study nights, separated by 7-day intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start19 Mar 2026
- Primary completion31 May 2026 (estimated)
- Study completion7 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, double-blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570472
- Sponsor's protocol ID
- S69706
- Other IDs
- 2024-518609-17-00
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of CBD on Sleep Quality Following Late Evening Exercise
- ClinicalTrials.gov ID
- NCT07570472
- Acronym / sponsor ID
- S69706
- Conditions
- Sleep Quality
- Keywords
- Cannabidiol, Sleep quality, Late evening exercise, Polysomnography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 7 Jun 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Exercise session 1 | Experimental | Drug: Cannabidiol or placebo, Behavioral: late evening exerciseParticipants perform a late evening exercise and receive placebo/CBD supplements |
| Exercise session 2 | Experimental | Drug: Cannabidiol or placebo, Behavioral: late evening exerciseParticipants perform a late evening exercise and receive placebo/CBD supplements |
| No exercise / rest session | Experimental | Drug: Cannabidiol or placeboParticipants do not perform a late evening exercise and receive placebo/CBD supplements |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol or placeboparticipants receive 2 x 200mg CBD or placebo | Drug | Exercise session 1, Exercise session 2, No exercise / rest session |
| late evening exerciseParticipants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep | Behavioural | Exercise session 1, Exercise session 2 |
Primary outcome
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
4 secondary outcomes
Sleep indices (other than sleep efficiency)
Time frame: Nightly assessment on three specific study nights, separated by 7-day intervals
Perceived sleep quality
Time frame: Assessment on three specific study mornings, separated by 7-day intervals
Circulating hormones involved in sleep and stress
Time frame: Assessment on three specific study nights, separated by 7-day intervals
Plasma and urinary catecholamines (adrenaline, noradrenaline, dopamine) and serotonin concentration
Time frame: Assessment on three specific study nights, separated by 7-day intervals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing late evening exercise in people with Sleep Quality, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep efficiency (time frame: Nightly assessment on three specific study nights, separated by 7-day intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.