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


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.

Intervention / Treatment

  • Sodium Oxybate (DRUG)
    Sodium oxybate h.s.
  • Sleep deprivation (BEHAVIORAL)
    36hr sleep deprivation

Condition or Disease

  • Amyloid-beta


  • Not Applicable
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 36 (ACTUAL)
    Funded by: Other|NIH
    Allocation: Randomized
    Primary Purpose: Other


    • Participant

    Clinical Trial Dates

    Start date: Dec 01, 2013
    Primary Completion: Jul 01, 2016 ACTUAL
    Completion Date: Jul 01, 2016 ACTUAL
    Study First Posted: Feb 14, 2014 ESTIMATED
    Results First Posted: Apr 26, 2018 ACTUAL
    Last Updated: Mar 26, 2018

    Sponsors / Collaborators

    Lead sponsor is responsible party
    Responsible Party: N/A

    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).

    Participant Groups

    • 7.5 grams of sodium oxybate

    • Sleep deprivation for up to 36 hours with no naps or other sleep periods

    • Participant will sleep as normal under the same controlled conditions in a clinical research unit

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 60
    Age Groups: Adult
    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

    Primary Outcomes
    • 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.

    More Details

    NCT Number: NCT02063217
    Other IDs: 201304030
    Study URL:
    Last updated: Sep 29, 2023