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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Sleep deprivation
Sponsored by
University Medical Center Nijmegen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring Alzheimer Disease, Cerebrospinal fluid, Sleep, Abeta

Eligibility Criteria

40 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Centre Nijmegen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Sleep deprivation

Control night

Arm Description

13 subjects will undergo full sleep deprivation these subjects are blind to allocation ntil they enter the study center

control night of unrestricted sleep in 13 other subjects

Outcomes

Primary Outcome Measures

Amyloid beta
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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2010
Last Updated
May 9, 2014
Sponsor
University Medical Center Nijmegen
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1. Study Identification

Unique Protocol Identification Number
NCT01194713
Brief Title
Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics
Acronym
AWAKE
Official Title
Losing Sleep Over Alzheimer's Disease? Effects of Sleep Deprivation on Cerebrospinal Fluid Amyloid-beta Dynamics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Nijmegen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer Disease, Cerebrospinal fluid, Sleep, Abeta

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep deprivation
Arm Type
Active Comparator
Arm Description
13 subjects will undergo full sleep deprivation these subjects are blind to allocation ntil they enter the study center
Arm Title
Control night
Arm Type
No Intervention
Arm Description
control night of unrestricted sleep in 13 other subjects
Intervention Type
Behavioral
Intervention Name(s)
Sleep deprivation
Intervention Description
subjects will undergo one night of full sleep deprivation
Primary Outcome Measure Information:
Title
Amyloid beta
Description
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.
Time Frame
6 timepoints during one night of sleep deprivation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Clinical Research Centre Nijmegen
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24887018
Citation
Ooms S, Overeem S, Besse K, Rikkert MO, Verbeek M, Claassen JA. Effect of 1 night of total sleep deprivation on cerebrospinal fluid beta-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.
Results Reference
derived

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

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