Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics (AWAKE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01194713
Recruitment Status : Completed
First Posted : September 3, 2010
Last Update Posted : May 13, 2014
Information provided by (Responsible Party):
Dr. J. Claassen, University Medical Center Nijmegen

September 1, 2010
September 3, 2010
May 13, 2014
March 2011
September 2013   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01194713 on Archive Site
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Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics
Losing Sleep Over Alzheimer's Disease? Effects of Sleep Deprivation on Cerebrospinal Fluid Amyloid-beta Dynamics

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.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Alzheimer Disease
Behavioral: Sleep deprivation
subjects will undergo one night of full sleep deprivation
  • Active Comparator: Sleep deprivation

    13 subjects will undergo full sleep deprivation

    these subjects are blind to allocation ntil they enter the study center

    Intervention: Behavioral: Sleep deprivation
  • No Intervention: Control night
    control night of unrestricted sleep in 13 other subjects
Ooms S, Overeem S, Besse K, Rikkert MO, Verbeek M, Claassen JA. Effect of 1 night of total sleep deprivation on cerebrospinal fluid β-amyloid 42 in healthy middle-aged men: a randomized clinical trial. JAMA Neurol. 2014 Aug;71(8):971-7. doi: 10.1001/jamaneurol.2014.1173.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2013
September 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent
  • Age 40-60 years
  • Male
  • Subject is in good health as established by medical history, physical examination, ECG and laboratory examination
  • Laboratory parameters (as described on in section 3.7 screening) should be within the normal ranges as applicable in RUNMC, Nijmegen, or clinically acceptable to the investigator
  • Normal sleep behaviour, Pittsburg Sleep Quality index score ≤5
  • MMSE 28 or higher
  • Medication free

Exclusion Criteria:

  • Presence of blood coagulopathy, established by medical history
  • Allergy to local anesthetic agents
  • Contra-indication for spinal catheter placement: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine
  • Subjects who are currently participating in another study or have participated in a clinical study within 30 days, based on their own report about participation history
  • Subjects with a history of drug or alcohol abuse
  • Subjects who are part of the study staff personnel or family members of the study staff personnel
Sexes Eligible for Study: Male
40 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Dr. J. Claassen, University Medical Center Nijmegen
University Medical Center Nijmegen
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University Medical Center Nijmegen
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP