Impact of sleep apnea and its treatment on memory and tau accumulation in the brain

  • STATUS
    Recruiting
  • End date
    Sep 21, 2025
Updated on 25 March 2022
cognitive impairment
mini-mental state examination
mild cognitive impairment
amyloid

Summary

The purpose of the research study is to address whether obstructive sleep apnea (OSA) represents a risk factor contributing to the development of Alzheimer’s disease (AD) that can be slowed by treatment with Positive Airway Pressure (PAP). Our preliminary data shows conversion to Mild Cognitive Impairment in self-reported PAP users is later than in those reporting no treatment and suggests that OSA may be a modifiable risk factor for AD. This study will build on that by evaluating the effect of PAP treatment on markers of AD, such as amyloid beta (Aβ), Tau levels, and neurofilament light chain (NfL) in cerebral spinal fluid (CSF) and blood plasma, and investigate the relationship between the amount of PAP use (adherence) and Tau levels.

Description

The purpose of the research study is to address whether obstructive sleep apnea (OSA) represents a risk factor contributing to the development of Alzheimer’s disease (AD) that can be slowed by treatment with Positive Airway Pressure (PAP). Our preliminary data shows conversion to Mild Cognitive Impairment in self-reported PAP users is later than in those reporting no treatment and suggests that OSA may be a modifiable risk factor for AD. This study will build on that by evaluating the effect of PAP treatment on markers of AD, such as amyloid beta (Aβ), Tau levels, and neurofilament light chain (NfL) in cerebral spinal fluid (CSF) and blood plasma, and investigate the relationship between the amount of PAP use (adherence) and Tau levels.
If you choose to participate you will be asked to complete 4 visits, which will take place over the course of over approximately 12 weeks. Visit 1 will occur at the Mount Sinai Integrative Sleep Center (MSISC), and will include a sleep interview, screening for Magnetic Resonance Imaging (MRI) safety, cognitive testing, a physical exam, and a blood draw. You will also be given an Actigraph watch to wear on your wrist for 2 weeks. Visit 2 will occur within the Mount Sinai BioMedical Engineering and Imaging Institute (BMEII) where we will obtain an image of your brain (MRI). .

Visits 1 and 2 may occur on the same day. Visit 3 will occur at Mount Sinai Interventional Neuroradiology where you will undergo a Fluoro-guided Lumbar Puncture (LP). Visits 1-3 will be completed before you start PAP therapy. Visit 4 occurs approximately 8-12 weeks after initiation of PAP therapy and includes another Fluoro-guided LP and blood draw. We will download your PAP adherence at this visit. There will be no delay in the start of your PAP therapy if you choose to participate in this study. If you participate you will receive the benefit of undergoing MRI study of your brain which are of significant value as they may offer some information regarding your brain health. If you are interested in learning more about this study, please continue to read below.

This study also offers the possibility to complete a 2nd brain MRI in individuals who refuse CSF collection, as completion of pre-treatment and post-treatment MRI’s will allow the possibility to assess potential benefits that result from OSA treatment with PAP.

Details
Condition Alzheimer's Disease, OSA, obstructive sleep apnea, CPAP, continuous positive airway pressure treatment
Clinical Study IdentifierTX291189
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female subjects with normal cognition and 60-75 years
Within normal limits on neurological and psychiatric examinations
All subjects enrolled will have both a CDR=0, a MMSE>27and declarative delayed memory composite scores from our test battery to be greater than -1.25 SDs from the age-adjusted mean of our normative sample
All subjects will have had a minimum of 12 years of education
Subjects will have newly diagnosed OSA with a minimum AHI4% of 15/hour or AHI3A #30/hour, subjective daytime Sleepiness as defined by an Epworth sleepiness score >= 10, and have been prescribed PAP (either CPAP or Auto-PAP) as therapy for OSA

Exclusion Criteria

Presence of sleep disorders other than OSA, including sleep hypoventilation, central sleep apnea/Cheyne Stokes respiration, periodic limb movement disorder, narcolepsy, etc
Performance of active shift work, or irregular sleep-wake rhythms (based on the actigraphy recordings): >=3 sleep episodes per 24-hr period or day to day variation in mean sleep onset or offset time of greater than 90 minutes
History of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders)
Subjects with a Fazekas scale >2 will be excluded. Significant history of alcoholism or drug abuse
History of psychiatric illness (e.g., schizophrenia, bipolar, PTSD, or life-long history of major depression)
Geriatric Depression Scale (short form)>5\. Insulin dependent diabetes. Evidence of clinically unstable cardiac, pulmonary, endocrine or hematological conditions.Physical impairment of such severity as to adversely affect the validity of psychological testing
Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging
History of a first-degree family member with early onset (age <60 years) dementia
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