- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00804804
Aging, Sleep, Cognitive Process (SOMVIE)
Aging,Sleep and Cognitive Process
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33076
- Genpphass
-
Toulouse, France, 31405
- Medes-Imps
-
Toulouse, France, 31300
- UH Purpan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Y1
young volunteers (20-30 years), morningness chronotype
|
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
|
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
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
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
Time Frame: every 3h45
|
every 3h45
|
Secondary Outcome Measures
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
Time Frame: every 3h45
|
every 3h45
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre PHILIP, MD,PHD, University Hospital Bordeaux France
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHUBX 2008/17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on BIOLOGICAL CLOCKS
-
Uppsala UniversityThe Swedish Research CouncilUnknownHealthy | Sleep Deprivation | Metabolic Disturbance | Biological ClocksSweden
-
Fundació EurecatCirce, S.L.Not yet recruiting
-
Centre Hospitalier Universitaire, AmiensRecruitingBiological SamplesFrance
-
DaacroISTITUTO KURZ ITALIA S.R.L.; Institut Kurz GmbH; Fattoria La Vialla di Gianni...CompletedBiological AvailabilityGermany
-
Wageningen UniversityCompletedBiological Availability
-
Alza Corporation, DE, USACompleted
-
Janssen Infectious Diseases BVBACompletedHealthy | Biological AvailabilityNetherlands
-
University of Massachusetts, AmherstNational Institutes of Health (NIH); National Institute on Aging (NIA); University...Recruiting
-
PfizerCompletedBiological AvailabilityUnited States
-
Xspray Pharma ABQPS Bioserve India Pvt LimitedCompleted
Clinical Trials on Sleep deprivation and multiple rest
-
Federal University of São PauloCompleted
-
Esther WerthCompletedIdiopathic Hypersomnia | Narcolepsy 1Switzerland
-
Yoav GimonRecruiting
-
Boston University Charles River CampusBrain & Behavior Research Foundation; One Mind; 1907 FoundationRecruiting
-
Charite University, Berlin, GermanyCompleted
-
University Medical Center NijmegenCompletedAlzheimer DiseaseNetherlands
-
University of OttawaRecruitingSleep Disturbance | Exercise | Aging | Thermoregulation | Heat ExchangeCanada
-
University of ZurichFonds für Verkehrssicherheit FVSCompletedSleep Deprivation | Sleepiness | Insufficient Sleep SyndromeSwitzerland
-
St Mary's University CollegeNot yet recruiting
-
Northwestern UniversityCompleted