We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aging, Sleep, Cognitive Process (SOMVIE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804804
First Posted: December 9, 2008
Last Update Posted: March 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Bordeaux
  Purpose
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

Condition Intervention
BIOLOGICAL CLOCKS Other: Sleep deprivation and multiple rest

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Aging,Sleep and Cognitive Process

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 [ Time Frame: every 3h45 ]

Secondary Outcome Measures:
  • 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 [ Time Frame: every 3h45 ]

Estimated Enrollment: 28
Study Start Date: December 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Y1
young volunteers (20-30 years), morningness chronotype
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
Experimental: Y2
young volunteers (20-30 years), eveningness chronotype
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
Experimental: O1
Aged volunteers (65-75 years), morningness chronotype
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
Experimental: O 2
aged volunteers (65-75 years), eveningness chronotype
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

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804804


Locations
France
Genpphass
Bordeaux, France, 33076
Uh Purpan
Toulouse, France, 31300
Medes-Imps
Toulouse, France, 31405
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Pierre PHILIP, MD,PHD University Hospital Bordeaux France
  More Information

Responsible Party: Jean Pierre LEROY/ Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00804804     History of Changes
Other Study ID Numbers: CHUBX 2008/17
First Submitted: December 8, 2008
First Posted: December 9, 2008
Last Update Posted: March 7, 2011
Last Verified: March 2011

Keywords provided by University Hospital, Bordeaux:
Sleep
aging
cognitives processes
constant routine


To Top