The Effect of CBD on Sleep Quality Following Late Evening Exercise
ConditionSleep Quality
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-40
SponsorKU Leuven
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Cannabidiol or placebo
Drugparticipants receive 2 x 200mg CBD or placebo
late evening exercise
BehavioralParticipants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep
Treatment groups
20 Participants
are divided into 3 treatment groupsGroup A: Exercise session 1Experimental treatment 2 interventions
Group B: Exercise session 2Experimental treatment 2 interventions
Group C: No exercise / rest sessionExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Nightly assessment on three specific study nights, separated by 7-day intervalsSecondary outcomes
1
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
Time frame
Nightly assessment on three specific study nights, separated by 7-day intervals2
Perceived sleep quality
Participants complete the St. Mary's Hospital questionnaire to evaluate their subjective sleep quality from the previous night
Time frame
Assessment on three specific study mornings, separated by 7-day intervals3
Circulating hormones involved in sleep and stress
Circulating hormones such as growth hormone, melatonin and cortisol are measured
Time frame
Assessment on three specific study nights, separated by 7-day intervals4
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.
Time frame
Assessment on three specific study nights, separated by 7-day intervals Source ClinicalTrials.gov