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Brain Sleep Deprivation MRI Effects (BEDTIME) (BEDTIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02741505
Recruitment Status : Withdrawn (Funding was not obtained)
First Posted : April 18, 2016
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The primary purpose of this study is to explore the underlying mechanisms that link sleep to Alzheimer's disease (AD), with special focus on the clearance of metabolites in the extracellular space of the brain during sleep. Subjects will wear an actigraph for 1 week to determine regular daytime activity and sleep patterns. Subjects will then undergo partial sleep deprivation followed by 4 hours of in-lab nocturnal polysomnography (NPSG). Participants will be be asked to stay awake and active all day after the partial sleep deprivation with a new actigraphy secured by a hospital band to assure participants remain awake. They will seep inside an MRI machine for 90 minutes on the following night during their usual bedtime (established by 1 week actigraphy study.) Morphologic imaging, flow imaging and diffusion kurtosis imaging (DKI) will be performed on a 3T Siemens scanner.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Device: Actigraph Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Open Masking, Micro Motionlogger Actigraph, 3T Siemens MRI, Sleep Deprivation, Nocturnal PSG
Estimated Study Start Date : June 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sleep Deprivation followed by Normal Sleep
Subjects will be sleep deprived at the sleep laboratory.
Device: Actigraph
Participants will be asked to wear an actigraph




Primary Outcome Measures :
  1. Measure of Interstitial Space Volume during sleep using MRI imaging [ Time Frame: 6 Months ]
    Data will be acquired using imaging sequences that comply with federal limits regarding radiofrequency energy deposition and gradient slew rates.


Secondary Outcome Measures :
  1. Changes in Cerebral Spinal Fluid volume measured by increases in the power of slow wave activity (SWA) [ Time Frame: 6 Months ]
    Data will be acquired using imaging sequences that comply with federal limits regarding radiofrequency energy deposition and gradient slew rates.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age range 21-30
  • Capable of giving informed consent

Exclusion Criteria:

  • Diagnosis of any brain disease or brain damage including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorders (e.g. Parkinson's disease or other movement disorders). Persons with silent cortical infarcts will be excluded. White matter lesions will not be exclusions.
  • History of major psychiatric illness (e.g., schizophrenia, bipolar or life long history of major depression)
  • Conditions that alter normal sleep patterns: irregular sleep-wake rhythms (based on one week at home monitoring with actigraphy), moderate to severe periodic limb movement while you sleep (PLMS) or Obstructive Sleep Apnea (OSA).
  • History of claustrophobia.
  • BMI≥30
  • Significant history of alcoholism or drug abuse.
  • Inability to avoid the use of alcohol or caffeine during the 48h before the MRI.
  • Current pregnancy or intent to become pregnant during the period of study.
  • Any electronic or ferromagnetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
  • Any medications adversely affecting cognition, blood pressure, glucose metabolism, or sleep will result in exclusion.

Information from the National Library of Medicine

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): NCT02741505


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Ricardo Osorio Suarez, MD New York University Medical School
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02741505    
Other Study ID Numbers: 15-00971
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NYU Langone Health:
cerebrospinal fluid (CSF)
sleep
Obstructive Sleep Apnea (OSA)
Sleep Disordered Breathing (SDB)
Period Limb Movement during Sleep (PLMS)
Additional relevant MeSH terms:
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Alzheimer Disease
Sleep Deprivation
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyssomnias
Sleep Wake Disorders
Neurologic Manifestations