Aging, Sleep, Cognitive Process
SOMVIE
Aging,Sleep and Cognitive Process
1 other identifier
interventional
28
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2008
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 8, 2008
CompletedFirst Posted
Study publicly available on registry
December 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedMarch 7, 2011
March 1, 2011
2.2 years
December 8, 2008
March 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (4)
Y1
EXPERIMENTALyoung volunteers (20-30 years), morningness chronotype
Y2
EXPERIMENTALyoung volunteers (20-30 years), eveningness chronotype
O1
EXPERIMENTALAged volunteers (65-75 years), morningness chronotype
O 2
EXPERIMENTALaged volunteers (65-75 years), eveningness chronotype
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Genpphass
Bordeaux, 33076, France
Uh Purpan
Toulouse, 31300, France
Medes-Imps
Toulouse, 31405, France
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre PHILIP, MD,PHD
University Hospital Bordeaux France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 8, 2008
First Posted
December 9, 2008
Study Start
December 1, 2008
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
March 7, 2011
Record last verified: 2011-03