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

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ClinicalTrials.gov Identifier: NCT02063217
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : March 8, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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
Amyloid-beta Drug: Sodium Oxybate Behavioral: Sleep deprivation

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).

Study Design

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
Primary Completion Date : July 2016
Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change in CSF amyloid beta concentration during sleep induction and sleep deprivation [ Time Frame: 36 hours of CSF collection ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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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


Locations
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)
Investigators
Principal Investigator: Brendan Lucey, MD Washington University Medical School
More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02063217     History of Changes
Other Study ID Numbers: 201304030
P50AG005681-30 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Amyloidosis
Sleep Deprivation
Proteostasis Deficiencies
Metabolic Diseases
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs