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Aging, Sleep, Cognitive Process (SOMVIE)

4. marts 2011 opdateret af: University Hospital, Bordeaux

Aging,Sleep and Cognitive Process

The aim of the study is to determine the impact of aging, circadian rhythms and sleep deprivation on executive performances. Volunteers will complete a 40-hour extended wakefulness period in constant condition (semi-recumbent posture in bed, constant dim light levels < 10 lux, food and liquid intake at regular intervals) in order to control the circadian system. The volunteers will not be allowed to sleep in the sleep deprivation protocol ("high sleep pressure protocol") and will adopt a short wakefulness/sleep cycle (150/75 minutes) in the multiple nap protocol ("low sleep pressure protocol"). Tests and scales will be repeated every 3H45

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Bordeaux, Frankrig, 33076
        • Genpphass
      • Toulouse, Frankrig, 31405
        • Medes-Imps
      • Toulouse, Frankrig, 31300
        • UH Purpan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Y1
young volunteers (20-30 years), morningness chronotype
Andet: Sleep deprivation and multiple rest
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
Eksperimentel: Y2
young volunteers (20-30 years), eveningness chronotype
Andet: Sleep deprivation and multiple rest
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
Eksperimentel: O1
Aged volunteers (65-75 years), morningness chronotype
Andet: Sleep deprivation and multiple rest
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
Eksperimentel: O 2
aged volunteers (65-75 years), eveningness chronotype
Andet: Sleep deprivation and multiple rest
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: every 3h45
every 3h45

Sekundære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: every 3h45
every 3h45

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Bordeaux

Efterforskere

  • Ledende efterforsker: Pierre PHILIP, MD,PHD, University Hospital Bordeaux France

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2008

Primær færdiggørelse (Faktiske)

1. februar 2011

Studieafslutning (Faktiske)

1. februar 2011

Datoer for studieregistrering

Først indsendt

8. december 2008

Først indsendt, der opfyldte QC-kriterier

8. december 2008

Først opslået (Skøn)

9. december 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. marts 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. marts 2011

Sidst verificeret

1. marts 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CHUBX 2008/17

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sleep deprivation and multiple rest

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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