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The Effect of CBD on Sleep Quality Following Late Evening Exercise

30. april 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgien, 3001
        • Rekruttering
        • Bakala Athletic Performance Facility
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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))

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise session 1
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
Eksperimentel: 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
Eksperimentel: No exercise / rest session
Participants do not perform a late evening exercise and receive placebo/CBD supplements
participants receive 2 x 200mg CBD or placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
sleep efficiency
Tidsramme: 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
Nightly assessment on three specific study nights, separated by 7-day intervals

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep indices (other than sleep efficiency)
Tidsramme: 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
Nightly assessment on three specific study nights, separated by 7-day intervals
Perceived sleep quality
Tidsramme: 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
Assessment on three specific study mornings, separated by 7-day intervals
Circulating hormones involved in sleep and stress
Tidsramme: Assessment on three specific study nights, separated by 7-day intervals
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
Tidsramme: 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.
Assessment on three specific study nights, separated by 7-day intervals

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. marts 2026

Primær færdiggørelse (Anslået)

31. maj 2026

Studieafslutning (Anslået)

7. juni 2026

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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