Trial record 2 of 9 for:    sleep deprivation OR sleep deficiency | Open Studies | NIH, U.S. Fed

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 2014 by Washington University School of Medicine
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02063217
First received: January 29, 2014
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 Phase
Changing CSF Amyloid-beta Levels With Sleep Modification
Drug: Sodium Oxybate
Behavioral: Sleep deprivation
Phase 4

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 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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

    • 18

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
  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 ClinicalTrials.gov identifier: NCT02063217

Contacts
Contact: Jennifer McLeland, MSW, MA 314-747-3819 mclelandj@neuro.wustl.edu
Contact: Cristina Toedebusch, BS 314-747-0646 toedebuschc@neuro.wustl.edu

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

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02063217     History of Changes
Other Study ID Numbers: 201304030, P50AG005681-30
Study First Received: January 29, 2014
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014