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CPAP Treatment of Obstructive Sleep Apnea for MCI

Recruiting

The purpose of this 1-year study is to determine whether treatment of obstructive sleep apnea with a continuous positive airway pressure (CPAP) machine can delay the progression of cognitive impairment in older adults with mild cognitive impairment (MCI).

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 75 Years All No
October 15, 2017
July 1, 2025
460

  • Moderate to severe obstructive sleep apnea (Apnea Hypopnea Index of 15 or fewer events per hour) or no apnea (less than 5 events per hour) as determined by a polysomnography sleep study
  • Modified Telephone Interview for Cognitive Status score of 28 to 35 (optional pre-screen test)
  • Clinical Dementia Rating Scale score of 0.5 or less
  • Mini-Mental State Examination score of 24 to 30 (exceptions may be made for participants with less than 8 years of education)
  • Memory impairment approximately 1 to 1.5 standard deviations below normal, as determined by Logical Memory II test on Wechshler Memory Scale; test performance approximately 1 to 1.5 standard deviations below normal in no more than one cognitive domain in addition to memory
  • Alzheimer's medications (cholinesterase inhibitors/memantine) must be stable for 12 weeks; other permitted medications (antidepressants, etc.) must be stable for at least 4 weeks
  • Geriatric Depression Scale score of less than 6 (not depressed)
  • Study partner who either lives with the participant, has contact at least 3 times per week in-person or via phone, or spends at least 10 hours per week in any combination of phone or in-person contact
  • Adequate visual and hearing ability to complete tests
  • Post-menopause or surgically sterile
  • Willing to undergo magnetic resonance imaging (MRI) and provide DNA for APOE E4 assessment
  • Completed at least 6 grades of education
  • Fluent in English or Spanish

  • Neurologic disease other than MCI, such as Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, head trauma followed by permanent neurologic deficits, or known congenital brain structure abnormalities
  • Brain tumor, seizure disorder, or subdural hematoma in past 6 months or post-stroke
  • MRI exclusions include pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body; however, participation is allowed without MRI
  • Psychiatric disorders, including uncontrolled major depression, newly diagnosed or exacerbated bipolar disorder, psychotic features, agitation, or behavioral problems in past 6 months
  • History of schizophrenia
  • Alcohol abuse or dependence in past 6 months
  • Significant systemic illness or unstable medical condition, such as heart disease, liver disease, thyroid disease (must be on stable dose of thyroid medication for more than 6 months), or cancer diagnosis in past 6 month
  • Significant laboratory abnormalities, such as vitamin B12 deficiency
  • Use of supplemental oxygen or hypoxemia (daytime oxyhemoglobin saturation less than 90 percent on room air)
  • Reside in a skilled nursing facility
  • Participation in another clinical trial or study involving neuropsychological measures conducted more than 2 times a year
  • Currently receiving and adherent to CPAP or bilevel pressure for obstructive sleep apnea
  • Obstructive sleep apnea inadequately treated with CPAP alone (i.e., requiring bilevel therapy or oxygen)
  • Impairment in 3 to 5 cognitive domains on neuropsychological tests

Some studies show that obstructive sleep apnea is associated with an increased risk of cognitive impairment. This study will test whether a CPAP device, a pressurized nasal/face mask worn during sleep to keep breathing airways open, helps improve cognitive function. Researchers are recruiting participants both with and without obstructive sleep apnea. Participants with obstructive sleep apnea will be randomly assigned to either consistent or non-consistent use of the CPAP device. Participants will undergo cognitive testing, activity monitoring, brain MRI scans, and an amyloid PET scan.

Name City State Zip Status Primary Contact
Washington University in St. Louis
Saint Louis Missouri 63130-4862 Recruiting Brandye Mazdra
314-566-7038
bmazdra@wustl.edu
University of Pennsylvania
Philadelphia Pennsylvania 19104 Recruiting Grace Nathanson
215-746-7465
nathansa@pennmedicine.upenn.edu
University of Texas at Austin
Austin Texas 78701 Recruiting Jamie L Fuentecilla, PhD
512-471-9462
jamie.fuentecilla@utexas.edu
University of Virginia
Charlottesville Virginia 22903 Recruiting Colleen Webber

cmn6x@hscmail.mcc.virginia.edu

University of Pennsylvania

  • National Institute on Aging (NIA)

Name Role Affiliation
Nalaka Gooneratne, MD Principal Investigator Associate Professor
Kathy Richards, PhD Principal Investigator Professor
David Wolk, MD Principal Investigator Associate Professor

Name Phone Email
Tara Hayden, MPH 215-573-6637 thayden@pennmedicine.upenn.edu

NCT03113461

Changing the Trajectory of Mild Cognitive Impairment With CPAP Treatment of Obstructive Sleep Apnea