Back to resultsBrain Sleep Deprivation MRI Effects (BEDTIME) (BEDTIME)
Primary Purpose
Alzheimer's Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Actigraph
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring cerebrospinal fluid (CSF), sleep, Obstructive Sleep Apnea (OSA), Sleep Disordered Breathing (SDB), Period Limb Movement during Sleep (PLMS)
Eligibility 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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sleep Deprivation followed by Normal Sleep
Arm Description
Subjects will be sleep deprived at the sleep laboratory.
Outcomes
Primary Outcome Measures
Measure of Interstitial Space Volume during sleep using MRI imaging
Data will be acquired using imaging sequences that comply with federal limits regarding radiofrequency energy deposition and gradient slew rates.
Secondary Outcome Measures
Changes in Cerebral Spinal Fluid volume measured by increases in the power of slow wave activity (SWA)
Data will be acquired using imaging sequences that comply with federal limits regarding radiofrequency energy deposition and gradient slew rates.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02741505
Brief Title
Brain Sleep Deprivation MRI Effects (BEDTIME)
Acronym
BEDTIME
Official Title
Open Masking, Micro Motionlogger Actigraph, 3T Siemens MRI, Sleep Deprivation, Nocturnal PSG
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Funding was not obtained
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
cerebrospinal fluid (CSF), sleep, Obstructive Sleep Apnea (OSA), Sleep Disordered Breathing (SDB), Period Limb Movement during Sleep (PLMS)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep Deprivation followed by Normal Sleep
Arm Type
Experimental
Arm Description
Subjects will be sleep deprived at the sleep laboratory.
Intervention Type
Device
Intervention Name(s)
Actigraph
Intervention Description
Participants will be asked to wear an actigraph
Primary Outcome Measure Information:
Title
Measure of Interstitial Space Volume during sleep using MRI imaging
Description
Data will be acquired using imaging sequences that comply with federal limits regarding radiofrequency energy deposition and gradient slew rates.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Changes in Cerebral Spinal Fluid volume measured by increases in the power of slow wave activity (SWA)
Description
Data will be acquired using imaging sequences that comply with federal limits regarding radiofrequency energy deposition and gradient slew rates.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Osorio Suarez, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing Access Criteria
The investigator who proposed to use the data.
Learn more about this trial
Brain Sleep Deprivation MRI Effects (BEDTIME)
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