Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction

Completed · Not applicable

Conditions studied: Amyloid-beta

In brief

The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) through modulation of the sleep-wake cycle.

Key facts

Study ID

NCT02063217

Run by

Washington University School of Medicine

People needed

36

Starts

2013-12-01

Expected to finish

2016-07-01

Last updated by the study team

2018-04-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• cognitively normal or CDR 0
• negative for amyloid deposition by PET Pittsburgh Compound-B (PIB) imaging or CSF amyloid-beta-42 concentration
• Age 18-60
• Average reported sleep time 6-10hrs

You may not qualify if…

• diagnosis of a sleep disorder such as sleep apnea, narcolepsy, or restless leg syndrome
• positive ambulatory sleep study for obstructive sleep apnea (AHI > 5 respiratory events per hour) that will be performed as part of initial screening prior to enrollment
• Clinical Dementia Rating (CDR) > 0
• tremor or other neurologic injury in the non-dominant upper extremity (such as stroke or tremor) that would prevent the use of actigraphy
• current sleep walking or other sleep parasomnia
• diagnosis and treatment of stroke, myocardial infarction or heart attack,
• coronary artery disease, atrial fibrillation, or congestive heart failure
• diagnosis and treatment of asthma or Chronic Obstructive Pulmonary Disease (COPD)
• diagnosis and treatment of bipolar disorder, major depression, or Schizophrenia
• current urinary or fecal incontinence
• currently on a low salt diet
• diagnosis and treatment of a neurologic disorder such as Parkinson's disease, epilepsy, multiple sclerosis
• currently taking any blood thinner medications such as warfarin, Plavix, or Aspirin
• kidney disease resulting in renal impairment
• liver disease resulting in hepatic dysfunction
• Pregnancy
• currently taking sedating medications such as benzodiazepines
• alcohol use at bedtime
• tobacco use
• BMI >40
• contraindication to lumbar puncture
• diabetes
• sleep schedule outside the range of bedtime: 8pm-12am and waketime 4am-8am
• self reported difficulty sleeping in an unfamiliar environment
• use of sedative-hypnotic medications

Where it is running

• Washington University Medical School — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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