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

NCT ID: NCT01194713

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-09-30

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sleep deprivation

13 subjects will undergo full sleep deprivation

these subjects are blind to allocation ntil they enter the study center

Group Type: ACTIVE_COMPARATOR

Sleep deprivation

Intervention Type: BEHAVIORAL

subjects will undergo one night of full sleep deprivation

Control night

control night of unrestricted sleep in 13 other subjects

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep deprivation

subjects will undergo one night of full sleep deprivation

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Medical Center Nijmegen

OTHER

Sponsor Role: lead

Responsible Party

Dr. J. Claassen

Dr. Jurgen Claassen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Research Centre Nijmegen

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 24887018 (View on PubMed)

Other Identifiers

AWAKE32920

Identifier Type: -

Identifier Source: org_study_id