Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
NCT ID: NCT02063217
Last Updated: 2018-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2013-12-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Sleep Induction
7.5 grams of sodium oxybate
Sodium Oxybate
Sodium oxybate h.s.
Sleep Deprivation
Sleep deprivation for up to 36 hours with no naps or other sleep periods
Sleep deprivation
36hr sleep deprivation
Control
Participant will sleep as normal under the same controlled conditions in a clinical research unit
No interventions assigned to this group
Interventions
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Sodium Oxybate
Sodium oxybate h.s.
Sleep deprivation
36hr sleep deprivation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Aging (NIA)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Brendan Lucey, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University Medical School
Locations
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Washington University Medical School
St Louis, Missouri, United States
Countries
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Other Identifiers
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201304030
Identifier Type: -
Identifier Source: org_study_id
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