Brain Sleep Deprivation MRI Effects (BEDTIME)

NCT02741505 | Withdrawn DMC FDA Device

• 1 other identifier: 15-00971
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

cerebrospinal fluid (CSF); sleep; Obstructive Sleep Apnea (OSA); Sleep Disordered Breathing (SDB); Period Limb Movement during Sleep (PLMS)

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Secondary Outcomes (1)

• Changes in Cerebral Spinal Fluid volume measured by increases in the power of slow wave activity (SWA)

  6 Months

Study Arms (1)

Sleep Deprivation followed by Normal Sleep

EXPERIMENTAL

Subjects will be sleep deprived at the sleep laboratory.

Device: Actigraph

Interventions

Actigraph DEVICE

Participants will be asked to wear an actigraph

Sleep Deprivation followed by Normal Sleep

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Ricardo Osorio Suarez, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 18, 2016
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)