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

Primary Purpose

Amyloid-beta

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium Oxybate
Sleep deprivation
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Amyloid-beta

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Sleep Induction

Sleep Deprivation

Control

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2014
Last Updated
March 26, 2018
Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02063217
Brief Title
Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Official Title
Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloid-beta

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Induction
Arm Type
Experimental
Arm Description
7.5 grams of sodium oxybate
Arm Title
Sleep Deprivation
Arm Type
Experimental
Arm Description
Sleep deprivation for up to 36 hours with no naps or other sleep periods
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participant will sleep as normal under the same controlled conditions in a clinical research unit
Intervention Type
Drug
Intervention Name(s)
Sodium Oxybate
Other Intervention Name(s)
Xyrem
Intervention Description
Sodium oxybate h.s.
Intervention Type
Behavioral
Intervention Name(s)
Sleep deprivation
Intervention Description
36hr sleep deprivation
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan Lucey, MD
Organizational Affiliation
Washington University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University Medical School
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

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

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