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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine Identifier:
First received: January 29, 2014
Last updated: February 4, 2015
Last verified: February 2015

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 Intervention
Drug: Sodium Oxybate
Behavioral: Sleep deprivation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in CSF amyloid beta concentration during sleep induction and sleep deprivation [ Time Frame: 36 hours of CSF collection ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: December 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02063217

Contact: Jennifer McLeland, MSW, MA 314-747-3819
Contact: Cristina Toedebusch, BS 314-747-0646

United States, Missouri
Washington University Medical School Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Jennifer McLeland, MSW, MA    314-747-3819   
Contact: Cristina Toedebusch, BS    314-747-0646   
Principal Investigator: Brendan Lucey, MD         
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Brendan Lucey, MD Washington University Medical School
  More Information

No publications provided

Responsible Party: Washington University School of Medicine Identifier: NCT02063217     History of Changes
Other Study ID Numbers: 201304030, P50AG005681-30
Study First Received: January 29, 2014
Last Updated: February 4, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Deprivation
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on August 26, 2015