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

University Medical Center Nijmegen

Status

Completed

Conditions

Alzheimer Disease

Treatments

Behavioral: Sleep deprivation

Study type

Interventional

Funder types

Other

Identifiers

NCT01194713

AWAKE32920

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

Male

Ages

40 to 60 years old

Volunteers

Accepts 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