Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-21 @ 10:10 PM
Study NCT ID:
NCT02741505
Status:
WITHDRAWN
Last Update Posted:
2020-07-13
First Post:
2016-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Sleep Deprivation MRI Effects (BEDTIME)
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Open Masking, Micro Motionlogger Actigraph, 3T Siemens MRI, Sleep Deprivation, Nocturnal PSG
Status:
WITHDRAWN
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding was not obtained
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEDTIME
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: