CClinicalTrials.gg
CompletedNCT03912571Updated Sep 5, 2021

Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment

An observational study in Sleep Disorder, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-09-05.

Sponsored by NYU Langone Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
28
Ages
55 Years to 90 Years
Sex
All
01

Study summary

The purpose of this study is to determine the sleep patterns of subjects with or without sleep disturbances (insomnia, sleep apnea) and compare these findings with their previous FDG/PIB PET, structural MRI and brain blood flow scams performed during their participation in the Following studies 'Alzheimer's Disease Core Center (ADCC) Clinical Evaluation' (IRB: 2942), MRI Progression Markers of Cognitive Decline in the Elderly' (IRB:09-0586), or 'Imaging Neuro inflammation in Alzheimer's Disease with [11C] Arachidonic Acid (AA) and PET'(IRB: 10-00442).

02

Conditions studied

03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's enrollment of 28 is below the median of 109 across 654 observational studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

80 cognitively healthy subjects (normal or MCI) previously enrolled in Alzheimer's Disease Core Center (ADCC) and CBH studies who have agreed to be contacted about future research studies will be asked to additionally participate in this study. The age range of the subjects will be of 55-90 years based on the incidence of dementia in middle age and elder adults.

Inclusion criteria

  • All subjects will have participated in prior CBH studies and have agreed to an FDG, PIB and MRI scans.

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of sleep apnea and under treatment with a continuous positive airway pressure (CPAP) machine.
  • Active depressive episode during the evaluation with a Geriatric Depression Scale score >7 and/or a Clinical Global Impression scale for depression score >4.
  • Moderate Cognitive decline (GDS >3).
  • Severe primary or secondary insomnia except insomnia due to SDB.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
28 participants (actual)
Patient registry
No

Groups and cohorts

  • Mild Cognitive Impairment (MCI)

    Patients with clinical dementia rating of 0.5 or a global deterioration scale of 3.

    Diagnostic Test: Structural 3T MRI · Diagnostic Test: MRI Based Perfusion Imaging · Diagnostic Test: VR-CO2 MRI Scans

  • Normal Cognition (NL)

    Clinical Dementia Rating \[CDR\] of 0 or Global Deterioration Scale \[GDS\] of 1-2

    Diagnostic Test: Structural 3T MRI · Diagnostic Test: MRI Based Perfusion Imaging · Diagnostic Test: VR-CO2 MRI Scans

Interventions

  • Diagnostic testStructural 3T MRI

    measures of global and hippocampal atrophy)

  • Diagnostic testMRI Based Perfusion Imaging

    brain blood flow

  • Diagnostic testVR-CO2 MRI Scans

    reduced vaso reactivity to carbon dioxide

06

What researchers measure

Primary outcomes

  1. Decreased cerebral blood flow (CBF)

    Measured by perfusion MRI

    Time frame: 1 Week

  2. Measure of vasoreactivity to CO2 (VRCO2)

    subjects will breath through a respiratory tube and CO2 will be meaured

    Time frame: 1 Week

  3. Increase in cortical AB plaque burden

    Measured by PIB PET

    Time frame: 1 Week

07

Study locations

1 site
  • NYU Langone Medical Center
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03912571
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Apr 11, 2019
Start date
Nov 13, 2011
Primary completion
Sep 2019
Completion
Sep 2019
Last update
Sep 5, 2021

Study contacts

Ricardo Osorio, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion