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- Essai clinique NCT01823263
Metabolic and Cognitive Parameters Following Partial Sleep Deprivation
27 novembre 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jonathan Cedernaes, M.D., PhD
- E-mail: jonathan.cedernaes@neuro.uu.se
Sauvegarde des contacts de l'étude
- Nom: Christian Benedict, PhD
- E-mail: christian.benedict@neuro.uu.se
Lieux d'étude
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Uppsala, Suède, 75105
- Recrutement
- Department of Neuroscience, Uppsala University
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Contact:
- Jonathan Cedernaes, M.D, PhD
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Contact:
- Christian Benedict, PhD
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Chercheur principal:
- Christian Benedict, PhD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 28 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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'.
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Les participants reçoivent un programme informatique qui leur donne la possibilité de choisir les portions d'une variété d'aliments qu'ils aimeraient idéalement consommer
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)
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Expérimental: 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'.
|
Les participants reçoivent un programme informatique qui leur donne la possibilité de choisir les portions d'une variété d'aliments qu'ils aimeraient idéalement consommer
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)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Memory tasks
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Circulating hormone levels
Délai: 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
Délai: Change in intake at around 1200 hours, following the respective nighttime intervention (NS or PSD)
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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.
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Change in intake at around 1200 hours, following the respective nighttime intervention (NS or PSD)
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Working memory function task
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Christian Benedict, PhD, Department of Neuroscience, Uppsala University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2013
Achèvement primaire (Anticipé)
1 mars 2015
Achèvement de l'étude (Anticipé)
1 mars 2015
Dates d'inscription aux études
Première soumission
21 février 2013
Première soumission répondant aux critères de contrôle qualité
28 mars 2013
Première publication (Estimation)
4 avril 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
2 décembre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 novembre 2014
Dernière vérification
1 novembre 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SleepPartialJCCB2013
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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