Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics (AWAKE)
Recruitment status was Recruiting
Introduction: Alzheimer's disease (AD) is characterized by neurodegeneration of the brain in the form of neurofibrillary tangles and plaques containing the amyloid-beta protein (Abeta). Recent animal studies have shown that extended wakefulness is associated with increased production of these Abeta proteins and that sleep leads to a marked fall in their production.
Aim: The investigators aim to distinguish a similar effect of sleep disturbance on cerebrospinal fluid (CSF) Abeta levels in humans, which may point out sleep disturbance as an important factor in AD development.
Methods: a cross-over study in 12 healthy male volunteers, measuring CSF Abeta levels during a sleep deprivation night and before and after a control night with unrestricted sleep.
Expected results: The investigators expect sleep deprivation to lead to an increase in CSF Abeta levels, as compared to the levels in the control night.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Losing Sleep Over Alzheimer's Disease? Effects of Sleep Deprivation on Cerebrospinal Fluid Amyloid-beta Dynamics|
- Amyloid beta [ Time Frame: 6 timepoints during one night of sleep deprivation ] [ Designated as safety issue: No ]Subjects will undergo one night of sleep deprivation before, during and after which a total of 9 CSF samples (6ml each) will be drawn through a spinal catheter. From these CSF samples Amyloid beta will be analysed.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Sleep deprivation
in 6 subjects the control night will precede the deprivation night (group 1), while in the other 6 subjects the control night will follow after the deprivation night (group 2), thus becoming a recovery night.
Behavioral: Sleep deprivation
Complete sleep deprivation for one night
No Intervention: Control night
control night of unrestricted sleep either before or after the sleep deprivation night
|Clinical Research Centre Nijmegen||Recruiting|
|Nijmegen, Gelderland, Netherlands, 6500HB|
|Contact: J AHR Claassen, PHD, MD +31 24 3616772 J.email@example.com|