Clinical trial NCT01194713: Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics
Official title: Losing Sleep Over Alzheimer's Disease? Effects of Sleep Deprivation on Cerebrospinal Fluid Amyloid-beta Dynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Cerebrospinal fluid
Sleep
Abeta
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
First posted: 2010-09-03
Enrollment: 26
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Amyloid beta
timeFrame: 6 timepoints during one night of sleep deprivation
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Clinical Research Centre Nijmegen
state: Gelderland
Study officials:
References:
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.