Brain Sleep Deprivation MRI Effects (BEDTIME)

Sponsor

NYU Langone Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02741505

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Device: Actigraph	N/A

Study Design

Study Type:

Interventional

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

Anticipated Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Measure of Interstitial Space Volume during sleep using MRI imaging [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.