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

Not Applicable

Completed

• Conditions: Alzheimer Disease
• Interventions: Behavioral: Sleep deprivation

• Registration Number: NCT01194713
• Lead Sponsor: University Medical Center Nijmegen

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 available

Study Timeline

• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Study Start: 2011-03
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Amyloid beta	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.

Trial Locations

Locations (1)

Clinical Research Centre Nijmegen; 🇳🇱 Nijmegen, Gelderland, Netherlands