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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
Information provided by (Responsible Party):
Dr. J. Claassen, University Medical Center Nijmegen

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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

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Clinical Research Centre Nijmegen
Nijmegen, Gelderland, Netherlands, 6500HB
Sponsors and Collaborators
University Medical Center Nijmegen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. J. Claassen, Dr. Jurgen Claassen, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT01194713    
Other Study ID Numbers: AWAKE32920
First Posted: September 3, 2010    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014
Keywords provided by Dr. J. Claassen, University Medical Center Nijmegen:
Alzheimer Disease
Cerebrospinal fluid
Additional relevant MeSH terms:
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Alzheimer Disease
Sleep Deprivation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Sleep Wake Disorders
Neurologic Manifestations