Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics (AWAKE)
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|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||Phase|
|Alzheimer Disease||Behavioral: Sleep deprivation||Not Applicable|
|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|
|Actual Primary Completion Date :||September 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194713
|Clinical Research Centre Nijmegen|
|Nijmegen, Gelderland, Netherlands, 6500HB|