We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02063217
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyloid-beta Drug: Sodium Oxybate Behavioral: Sleep deprivation Not Applicable

Detailed Description:
The purpose of this research study is to investigate whether or not increasing or decreasing duration of sleep over one night will change the concentration of amyloid-beta in cerebral spinal fluid (CSF).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Study Start Date : December 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sleep Induction
7.5 grams of sodium oxybate
Drug: Sodium Oxybate
Sodium oxybate h.s.
Other Name: Xyrem

Experimental: Sleep Deprivation
Sleep deprivation for up to 36 hours with no naps or other sleep periods
Behavioral: Sleep deprivation
36hr sleep deprivation

No Intervention: Control
Participant will sleep as normal under the same controlled conditions in a clinical research unit

Primary Outcome Measures :
  1. Percent Increase From Mean Baseline (07:00 to 19:00) of Cerebrospinal Fluid (CSF) Amyloid Beta During Sleep Induction and Sleep Deprivation Between 01:00 and 11:00 From Baseline [ Time Frame: Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00 ]
    Overnight (01:00 to 11:00) differences in CSF amyloid beta from baseline (07:00 to 19:00) between 1) sleep-deprived and control participants and 2) sleep-induced and control participants.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • inability to get in and out of bed
  • history or presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or patient report
  • history of drug abuse within the past 6 months
  • positive score on 2 or more categories on the Berlin questionnaire
  • participation in another investigational medicinal product or investigational device within the last 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063217

Layout table for location information
United States, Missouri
Washington University Medical School
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Layout table for investigator information
Principal Investigator: Brendan Lucey, MD Washington University Medical School
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02063217    
Other Study ID Numbers: 201304030
P50AG005681-30 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2014    Key Record Dates
Results First Posted: April 26, 2018
Last Update Posted: April 26, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Deprivation
Proteostasis Deficiencies
Metabolic Diseases
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs