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

Tracking Information
First Submitted Date  ICMJE September 1, 2010
First Posted Date  ICMJE September 3, 2010
Last Update Posted Date May 13, 2014
Study Start Date  ICMJE March 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01194713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics
Official Title  ICMJE Losing Sleep Over Alzheimer's Disease? Effects of Sleep Deprivation on Cerebrospinal Fluid Amyloid-beta Dynamics
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Behavioral: Sleep deprivation
subjects will undergo one night of full sleep deprivation
Study Arms  ICMJE
  • 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
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2014)
26
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2010)
12
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01194713
Other Study ID Numbers  ICMJE AWAKE32920
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. J. Claassen, University Medical Center Nijmegen
Study Sponsor  ICMJE University Medical Center Nijmegen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Medical Center Nijmegen
Verification Date May 2014

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