The Effect of CBD on Sleep Quality Following Late Evening Exercise

NCT07570472 | Recruiting Phase 2

• 2 other identifiers: S697062024-518609-17-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Cannabidiol; Sleep quality; Late evening exercise; Polysomnography

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (4)

• Sleep indices (other than sleep efficiency)

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

• Perceived sleep quality

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

• Circulating hormones involved in sleep and stress

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

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

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

Study Arms (3)

Exercise session 1

EXPERIMENTAL

Participants perform a late evening exercise and receive placebo/CBD supplements

Drug: Cannabidiol or placebo; Behavioral: late evening exercise

Exercise session 2

EXPERIMENTAL

Participants perform a late evening exercise and receive placebo/CBD supplements

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

Drug: Cannabidiol or placebo

Interventions

Cannabidiol or placebo DRUG

participants receive 2 x 200mg CBD or placebo

Exercise session 1; Exercise session 2; No exercise / rest session

late evening exercise BEHAVIORAL

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

Exercise session 1; Exercise session 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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))

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Bakala Athletic Performance Facility

Leuven, Vlaams-Brabant, 3001, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 7, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)