The Effect of CBD on Sleep Quality Following Late Evening Exercise
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Bélgica, 3001
- Reclutamiento
- Bakala Athletic Performance Facility
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Contacto:
- Prof. Koppo
- Número de teléfono: +32 16 37 26 80
- Correo electrónico: katrien.koppo@kuleuven.be
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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))
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: 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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Experimental: Exercise session 2
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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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sleep efficiency
Periodo de tiempo: 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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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sleep indices (other than sleep efficiency)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- S69706
- 2024-518609-17-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .