- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00804804
Aging, Sleep, Cognitive Process (SOMVIE)
Aging,Sleep and Cognitive Process
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Bordeaux, Francia, 33076
- Genpphass
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Toulouse, Francia, 31405
- Medes-Imps
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Toulouse, Francia, 31300
- UH Purpan
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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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
Lasso di tempo: every 3h45
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every 3h45
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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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
Lasso di tempo: every 3h45
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every 3h45
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Pierre PHILIP, MD,PHD, University Hospital Bordeaux France
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CHUBX 2008/17
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Sleep deprivation and multiple rest
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VA Office of Research and DevelopmentRitiratoDisturbi del sonno e della veglia | Disturbi del sonno | Disturbi legati al sonnoStati Uniti
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Assiut UniversityNon ancora reclutamentoAdolescenti | Disturbi psichiatrici | Diabete mellito di tipo 1