- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07570472
The Effect of CBD on Sleep Quality Following Late Evening Exercise
30. april 2026 oppdatert av: KU Leuven
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgia, 3001
- Rekruttering
- Bakala Athletic Performance Facility
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Ta kontakt med:
- Prof. Koppo
- Telefonnummer: +32 16 37 26 80
- E-post: katrien.koppo@kuleuven.be
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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))
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Exercise session 1
Participants perform a late evening exercise and receive placebo/CBD supplements
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participants receive 2 x 200mg CBD or placebo
Participants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep
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Eksperimentell: Exercise session 2
Participants perform a late evening exercise and receive placebo/CBD supplements
|
participants receive 2 x 200mg CBD or placebo
Participants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep
|
|
Eksperimentell: No exercise / rest session
Participants do not perform a late evening exercise and receive placebo/CBD supplements
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participants receive 2 x 200mg CBD or placebo
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
sleep efficiency
Tidsramme: Nightly assessment on three specific study nights, separated by 7-day intervals
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the primary outcome of the current study is the parameter sleep efficiency (SE = time asleep (min) / time in bed (min)) measured by PSG
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Nightly assessment on three specific study nights, separated by 7-day intervals
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sleep indices (other than sleep efficiency)
Tidsramme: Nightly assessment on three specific study nights, separated by 7-day intervals
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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
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Nightly assessment on three specific study nights, separated by 7-day intervals
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Perceived sleep quality
Tidsramme: Assessment on three specific study mornings, separated by 7-day intervals
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Participants complete the St. Mary's Hospital questionnaire to evaluate their subjective sleep quality from the previous night
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Assessment on three specific study mornings, separated by 7-day intervals
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Circulating hormones involved in sleep and stress
Tidsramme: Assessment on three specific study nights, separated by 7-day intervals
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Circulating hormones such as growth hormone, melatonin and cortisol are measured
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Assessment on three specific study nights, separated by 7-day intervals
|
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Plasma and urinary catecholamines (adrenaline, noradrenaline, dopamine) and serotonin concentration
Tidsramme: Assessment on three specific study nights, separated by 7-day intervals
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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.
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Assessment on three specific study nights, separated by 7-day intervals
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. mars 2026
Primær fullføring (Antatt)
31. mai 2026
Studiet fullført (Antatt)
7. juni 2026
Datoer for studieregistrering
Først innsendt
30. april 2026
Først innsendt som oppfylte QC-kriteriene
30. april 2026
Først lagt ut (Faktiske)
6. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- S69706
- 2024-518609-17-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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