NCT00804804

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

2.2 years

First QC Date

December 8, 2008

Last Update Submit

March 4, 2011

Conditions

Keywords

Sleepagingcognitives processesconstant routine

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

EXPERIMENTAL

young volunteers (20-30 years), morningness chronotype

Other: Sleep deprivation and multiple rest

Y2

EXPERIMENTAL

young volunteers (20-30 years), eveningness chronotype

Other: Sleep deprivation and multiple rest

O1

EXPERIMENTAL

Aged volunteers (65-75 years), morningness chronotype

Other: Sleep deprivation and multiple rest

O 2

EXPERIMENTAL

aged volunteers (65-75 years), eveningness chronotype

Other: Sleep deprivation and multiple rest

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

Y1

Eligibility Criteria

Age20 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Uh Purpan

Toulouse, 31300, France

Location

Medes-Imps

Toulouse, 31405, France

Location

Study Officials

  • Pierre PHILIP, MD,PHD

    University Hospital Bordeaux France

    PRINCIPAL INVESTIGATOR

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

Locations