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- Ensayo clínico NCT01823263
Metabolic and Cognitive Parameters Following Partial Sleep Deprivation
27 de noviembre de 2014 actualizado por: Uppsala University
Metabolic and Cognitive Effects of Sleep Deprivation
The purpose of this study is to determine whether partial sleep deprivation, as compared with normal sleep, influences certain metabolic and cognitive parameters, related to food intake, hunger and memory functions, when participants are shielded from external time cues.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
It is predicted that partial sleep deprivation negatively affects the hormonal status, e.g.
upregulating ghrelin and other hunger-promoting hunger hormones, while showing impaired memory functions.
It is also predicted that participants will tend to increase their desired portion sizes after partial sleep deprivation, compared with after a normal night's sleep.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Uppsala, Suecia, 75105
- Reclutamiento
- Department of Neuroscience, Uppsala University
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Contacto:
- Jonathan Cedernaes, M.D, PhD
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Contacto:
- Christian Benedict, PhD
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Investigador principal:
- Christian Benedict, PhD
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 28 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- Male
- Age 20-28y
- Healthy (self-reported) and not on medication
- Non-smoking
- Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported and verified by sleep diaries)
- Normal dietary habits (regular meal pattern with daily breakfast)
Exclusion Criteria:
- Major illness
- Taking any serious medications
- Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
- Any dietary issues with the food items provided
- A history of endocrine, neurological or psychiatric disorders
- Shift work in the previous 3 months
- Travel over several time zones within the previous two months
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Partial sleep deprivation
Partial sleep deprivation: participants will have a 4-h sleep opportunity before a 'Blood Sample' will be taken, and the 'Memory tasks', 'Working memory function task' and 'Portion size task' will be performed.
This will be followed by an 'Interference task', followed by repeated blood sampling and an 'Intake task'.
|
Los participantes reciben un programa de computadora que les da la oportunidad de elegir las porciones de una variedad de alimentos que les gustaría consumir idealmente.
In the morning following partial sleep deprivation or normal sleep, a blood sample will be taken to assess the level of metabolism-linked and neurodegenerative-linked molecules, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as ghrelin
30-minute interference task
Participants will be allowed to learn a procedural memory task before going to bed.
Participants will be retested in the morning to assess their change in performance.
Other memory tests will also be given to assess the working memory performance in the morning following the intervention.
After a normal night of sleep or partial sleep deprivation, participants are presented with an ad libitum meal choice and can select the amount to ingest during a limited time window.
Amount and selection will be recorded
Participants will be evaluated on their working memory performance in the morning following either nighttime intervention (NS or PSD)
|
|
Experimental: Normal sleep
Normal sleep: participants will have an 8-h sleep opportunity before a 'Blood Sample' will be taken, and the 'Memory tasks', 'Working memory function task' and 'Portion size task' will be performed.
This will be followed by an 'Interference task', followed with repeated blood sampling and an 'Intake task'.
|
Los participantes reciben un programa de computadora que les da la oportunidad de elegir las porciones de una variedad de alimentos que les gustaría consumir idealmente.
In the morning following partial sleep deprivation or normal sleep, a blood sample will be taken to assess the level of metabolism-linked and neurodegenerative-linked molecules, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as ghrelin
30-minute interference task
Participants will be allowed to learn a procedural memory task before going to bed.
Participants will be retested in the morning to assess their change in performance.
Other memory tests will also be given to assess the working memory performance in the morning following the intervention.
After a normal night of sleep or partial sleep deprivation, participants are presented with an ad libitum meal choice and can select the amount to ingest during a limited time window.
Amount and selection will be recorded
Participants will be evaluated on their working memory performance in the morning following either nighttime intervention (NS or PSD)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Memory tasks
Periodo de tiempo: Change in memory performance between learning (at 2230 hours in NS and PSD condition) before going to sleep, and at 0800 and 0930 hours (following PSD or NS)
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Procedural memory performance after learning a procedural memory task close to going to bed, followed by either partial sleep deprivation (PSD) or normal sleep (NS), and comparing the performance the following morning at two time points.
Participants spatial memory performance in the morning at two time points, following PSD will also be compared with that following NS, after having learned such a memory task in the evening before going to bed.
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Change in memory performance between learning (at 2230 hours in NS and PSD condition) before going to sleep, and at 0800 and 0930 hours (following PSD or NS)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Circulating hormone levels
Periodo de tiempo: Change in circulating hormone levels and other metabolism-linked and neurodegeneration-associated molecules at 0730, 0830, 0910, 0925, 0940, 1010, 1040, 1105, and 1150 hours following the respective nighttime intervention and after the interference task
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Interference task given at 0900 hours
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Change in circulating hormone levels and other metabolism-linked and neurodegeneration-associated molecules at 0730, 0830, 0910, 0925, 0940, 1010, 1040, 1105, and 1150 hours following the respective nighttime intervention and after the interference task
|
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Intake task
Periodo de tiempo: Change in intake at around 1200 hours, following the respective nighttime intervention (NS or PSD)
|
Participants are presented with an ad libitum meal choice and can select the amount to ingest during a limited time window.
Amount and selection will be recorded.
|
Change in intake at around 1200 hours, following the respective nighttime intervention (NS or PSD)
|
|
Working memory function task
Periodo de tiempo: Change in memory performance at 0800 hours and after the interference task again at 0930 hours (between and following PSD or NS)
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Participants will be evaluated on their working memory performance in the morning following either nighttime intervention (NS or PSD) and before and after an interference task
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Change in memory performance at 0800 hours and after the interference task again at 0930 hours (between and following PSD or NS)
|
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Portion Size Task
Periodo de tiempo: Change in selected portion size from baseline (at 0800 hours following the nighttime intervention), to one hour later, i.e. after an interference task
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Participants will be evaluated on their tendency to choose larger or smaller portions of a variety of meal items on a computer screen.
This will be conducted both following partial sleep deprivation and normal sleep, and changes before and after a short interference task will be compared between these two conditions.
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Change in selected portion size from baseline (at 0800 hours following the nighttime intervention), to one hour later, i.e. after an interference task
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Christian Benedict, PhD, Department of Neuroscience, Uppsala University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2013
Finalización primaria (Anticipado)
1 de marzo de 2015
Finalización del estudio (Anticipado)
1 de marzo de 2015
Fechas de registro del estudio
Enviado por primera vez
21 de febrero de 2013
Primero enviado que cumplió con los criterios de control de calidad
28 de marzo de 2013
Publicado por primera vez (Estimar)
4 de abril de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de diciembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
27 de noviembre de 2014
Última verificación
1 de noviembre de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SleepPartialJCCB2013
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. .
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