Aging, Sleep, Cognitive Process

Aging,Sleep and Cognitive Process

Sponsors

Lead Sponsor: University Hospital, Bordeaux

Source University Hospital, Bordeaux
Brief Summary

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

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

Overall Status Completed
Start Date December 2008
Completion Date February 2011
Primary Completion Date February 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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 every 3h45
Secondary Outcome
Measure Time Frame
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 every 3h45
Enrollment 28
Condition
Intervention

Intervention Type: Other

Intervention Name: Sleep deprivation and multiple rest

Description: 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

Arm Group Label: Y1

Intervention Type: Other

Intervention Name: Sleep deprivation and multiple rest

Description: 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

Arm Group Label: Y2

Intervention Type: Other

Intervention Name: Sleep deprivation and multiple rest

Description: 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

Arm Group Label: O1

Intervention Type: Other

Intervention Name: Sleep deprivation and multiple rest

Description: 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

Arm Group Label: O 2

Eligibility

Criteria:

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).

Gender: Male

Minimum Age: 20 Years

Maximum Age: 75 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Pierre PHILIP, MD,PHD Principal Investigator University Hospital Bordeaux France
Location
Facility:
Genpphass | Bordeaux, 33076, France
Uh Purpan | Toulouse, 31300, France
Medes-Imps | Toulouse, 31405, France
Location Countries

France

Verification Date

March 2011

Responsible Party

Name Title: Jean Pierre LEROY/ Clinical Research and Innovation Director

Organization: University Hospital, Bordeaux

Keywords
Has Expanded Access No
Number Of Arms 4
Arm Group

Label: Y1

Type: Experimental

Description: young volunteers (20-30 years), morningness chronotype

Label: Y2

Type: Experimental

Description: young volunteers (20-30 years), eveningness chronotype

Label: O1

Type: Experimental

Description: Aged volunteers (65-75 years), morningness chronotype

Label: O 2

Type: Experimental

Description: aged volunteers (65-75 years), eveningness chronotype

Acronym SOMVIE
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov