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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518609-17-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise session 1 | Experimental | Participants perform a late evening exercise and receive placebo/CBD supplements |
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| Exercise session 2 | Experimental | Participants perform a late evening exercise and receive placebo/CBD supplements |
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| No exercise / rest session | Experimental | Participants do not perform a late evening exercise and receive placebo/CBD supplements |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol or placebo | Drug | participants receive 2 x 200mg CBD or placebo |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakala Athletic Performance Facility | Recruiting | Leuven | Vlaams-Brabant | 3001 | Belgium |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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randomized, double-blind, placebo-controlled
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| late evening exercise | Behavioral | Participants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep |
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| 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 |
| D001523 |
| Mental Disorders |