- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00804804
Aging, Sleep, Cognitive Process (SOMVIE)
Aging,Sleep and Cognitive Process
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Social evolutions (nocturnal activity, shift work) have consequently reduced average sleep duration average. In addition, aging leads to a physiological reduction of nocturnal sleep duration.
Many studies have shown that extended wakefulness impairs nocturnal performances measured with a simple reaction time test (SRTT) and that this decrement is also age-related. In deed, young subjects (20-30 years) are more affected than old subjects (50-60 years) during an extended wakefulness period.
The results obtained in confinement constant conditions, associated to a high or low sleep pressure, show that this difference observed between young and old subjects should be essentially related to a reduced circadian regulation (ex : reduced melatonin secretion) with age rather than to a reduced sleep pressure (homeostatic regulation) as previously suggested. However, studies on confinement have shown that sleep pressure (identified during the sleep period with the EEG delta band) could be reduced with aging specifically on the anterior brain regions (frontal regions).
It is well-known that executive performances (related to frontal lobes functioning) are affected by extended wakefulness, but respective effects of age, circadian system and sleep pressure in this decrement remain unknown.
The aim of this study is to determine the evolution of the executive functions during a 40-hour extended wakefulness period ("high sleep pressure protocol") or during a multiple nap protocol ("low sleep pressure protocol") according to the subjects' age, in constant experimental conditions of confinement.
It's a repeated measurements study with protocol (sleep deprivation and multiple naps) and time of day as within factors and age group (young versus older subjects) as between factor
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Bordeaux, France, 33076
- Genpphass
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Toulouse, France, 31405
- Medes-Imps
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Toulouse, France, 31300
- UH Purpan
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- excessive daytime sleepiness (Epworth Sleepiness Scale score > 9),
- sleep complaint such as sleep apnea or insomnia (Basic Nordic Sleep Questionnaire, items score < 4 except questions 3, 4 and 15a for aged volunteers),
- not intermediate in terms of morningness and eveningness according to the Horne-Ostberg questionnaire for young volunteers
- absence of psychopathology evidenced during psychologist interview or on the Symptom Check List (SCL-90R score>59)
- sleep efficiency evidenced by actimetry (>85%) during 7 days
- absence of apnea/hypopnea syndrome (RDI<15)
- absence of periodic movement disorder (MPS<15)
- regular sleep schedule during 3 days before study participation
- affiliated to the french health care system
Exclusion Criteria:
- volunteers with sleep disorders or organic disorders affecting sleep,
- poor sleep hygiene or abnormal usual sleep patterns,
- night workers or shift-workers,
- substance abusers (caffeine, drug, or alcohol).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Y1
young volunteers (20-30 years), morningness chronotype
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To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
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Expérimental: Y2
young volunteers (20-30 years), eveningness chronotype
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To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
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Expérimental: O1
Aged volunteers (65-75 years), morningness chronotype
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To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
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Expérimental: O 2
aged volunteers (65-75 years), eveningness chronotype
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To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Executive functions will be evaluated by a Go/NoGo task and a Stop Signal. Performances will be measured with a visual simple reaction time task
Délai: every 3h45
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every 3h45
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Nocturnal sleep quality before and after 2 constant conditions measured by PSG Sleep pressure quantified by Karolinska test and EEG delta band Subjective sleepiness and fatigue evaluated by Karolinska sleepiness scale and visual analogue scale
Délai: every 3h45
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every 3h45
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pierre PHILIP, MD,PHD, University Hospital Bordeaux France
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- CHUBX 2008/17
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