Aging, Sleep, Cognitive Process

NCT ID: NCT00804804

Last Updated: 2011-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-02-28

Brief Summary

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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

Detailed Description

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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

Conditions

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BIOLOGICAL CLOCKS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Y1

young volunteers (20-30 years), morningness chronotype

Group Type EXPERIMENTAL

Sleep deprivation and multiple rest

Intervention Type OTHER

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

Y2

young volunteers (20-30 years), eveningness chronotype

Group Type EXPERIMENTAL

Sleep deprivation and multiple rest

Intervention Type OTHER

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

O1

Aged volunteers (65-75 years), morningness chronotype

Group Type EXPERIMENTAL

Sleep deprivation and multiple rest

Intervention Type OTHER

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

O 2

aged volunteers (65-75 years), eveningness chronotype

Group Type EXPERIMENTAL

Sleep deprivation and multiple rest

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Bordeaux

Principal Investigators

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Pierre PHILIP, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux France

Locations

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Genpphass

Bordeaux, , France

Site Status

Uh Purpan

Toulouse, , France

Site Status

Medes-Imps

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2008/17

Identifier Type: -

Identifier Source: org_study_id

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