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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University Medical Center Nijmegen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01194713
First received: September 1, 2010
Last updated: May 17, 2011
Last verified: April 2011
History of Changes
  Purpose

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 cross-over study in 12 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 Intervention
Alzheimer Disease
 Behavioral: Sleep deprivation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Losing Sleep Over Alzheimer's Disease? Effects of Sleep Deprivation on Cerebrospinal Fluid Amyloid-beta Dynamics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Center Nijmegen:

Primary Outcome Measures:
  • Amyloid beta [ Time Frame: 6 timepoints during one night of sleep deprivation ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: March 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sleep deprivation
in 6 subjects the control night will precede the deprivation night (group 1), while in the other 6 subjects the control night will follow after the deprivation night (group 2), thus becoming a recovery night.
 Behavioral: Sleep deprivation
Complete sleep deprivation for one night
No Intervention: Control night
control night of unrestricted sleep either before or after the sleep deprivation night

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194713

Locations
Netherlands
Clinical Research Centre Nijmegen Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: J AHR Claassen, PHD, MD     +31 24 3616772     J.claassen@ger.umcn.nl    
Sponsors and Collaborators
University Medical Center Nijmegen
  More Information

No publications provided

Responsible Party: Dr. Jurgen A.H.R. Claassen, Radboud University Nijmegen Medical Center, Department of Clinical Geriatrics
ClinicalTrials.gov Identifier: NCT01194713     History of Changes
Other Study ID Numbers: AWAKE32920
Study First Received: September 1, 2010
Last Updated: May 17, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Center Nijmegen:
Alzheimer Disease
Cerebrospinal fluid
Sleep
Abeta

Additional relevant MeSH terms:
Alzheimer Disease
Sleep Deprivation
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013