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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Quality
• Intervention / Treatment: Drug: Cannabidiol or placebo; Behavioral: late evening exercise

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3001
      • Recruiting
      • Bakala Athletic Performance Facility
      • Contact: Prof. Koppo; Phone Number: +32 16 37 26 80; Email: katrien.koppo@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise session 1; Participants perform a late evening exercise and receive placebo/CBD supplements	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
Experimental: Exercise session 2; Participants perform a late evening exercise and receive placebo/CBD supplements	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
Experimental: No exercise / rest session; Participants do not perform a late evening exercise and receive placebo/CBD supplements	Drug: Cannabidiol or placebo; participants receive 2 x 200mg CBD or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	Assessment on three specific study nights, separated by 7-day intervals

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 7, 2026

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Polysomnography; Sleep quality; Cannabidiol; Late evening exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Cannabidiol
• Other Study ID Numbers: S69706; 2024-518609-17-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No