Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics (AWAKE)
|ClinicalTrials.gov Identifier: NCT01194713|
Recruitment Status : Completed
First Posted : September 3, 2010
Last Update Posted : May 13, 2014
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 study in 26 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.
|Condition or disease||Intervention/treatment|
|Alzheimer Disease||Behavioral: Sleep deprivation|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Losing Sleep Over Alzheimer's Disease? Effects of Sleep Deprivation on Cerebrospinal Fluid Amyloid-beta Dynamics|
|Study Start Date :||March 2011|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2013|
Active Comparator: Sleep deprivation
13 subjects will undergo full sleep deprivation
these subjects are blind to allocation ntil they enter the study center
Behavioral: Sleep deprivation
subjects will undergo one night of full sleep deprivation
No Intervention: Control night
control night of unrestricted sleep in 13 other subjects
- Amyloid beta [ Time Frame: 6 timepoints during one night of sleep deprivation ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194713
|Clinical Research Centre Nijmegen|
|Nijmegen, Gelderland, Netherlands, 6500HB|