Sleep Quality
Conditions
Keywords
Cannabidiol, Sleep quality, Late evening exercise, Polysomnography
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.
Interventions
participants receive 2 x 200mg CBD or placebo
BEHAVIORALlate evening exercise
Participants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep
Sponsors
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
randomized, double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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))
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sleep efficiency | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep indices (other than sleep efficiency) | Nightly assessment on three specific study nights, separated by 7-day intervals | 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 |
| Perceived sleep quality | Assessment on three specific study mornings, separated by 7-day intervals | Participants complete the St. Mary's Hospital questionnaire to evaluate their subjective sleep quality from the previous night |
| Circulating hormones involved in sleep and stress | Assessment on three specific study nights, separated by 7-day intervals | Circulating hormones such as growth hormone, melatonin and cortisol are measured |
| Plasma and urinary catecholamines (adrenaline, noradrenaline, dopamine) and serotonin concentration | Assessment on three specific study nights, separated by 7-day intervals | 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. |
Countries
Belgium
Outcome results
None listed