Alzheimer's Disease Education and Referral Center

Mild Cognitive Impairment and Obstructive Sleep Apnea (MEMORIES)

Mild Cognitive Impairment and Obstructive Sleep Apnea (MEMORIES)

Overall Status: 
No longer recruiting
Brief Description: 

We are conducting a pilot clinical trial to compare the effects of active continuous positive airway pressure (CPAP) versus sham CPAP on cognitive and everyday function in 110 older adults with mild cognitive impairment (MCI) and obstructive sleep apnea.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
89 Years
Both
No
Inclusion Criteria: 

  • Moderate to severe obstructive sleep apnea as defined by an apnea-hypopnea index (AHI) score of 15 or greater, using either the Apnea Risk Evaluation System (ARES) or diagnostic polysomnography
  • Score of 11 or less on the Dementia Severity Rating Scale
  • Education-adjusted total score of less than 26 on the Montreal Cognitive Assessment
  • Education-adjusted score of 28-35 (inclusive) on the Telephone Interview for Cognitive Status Modified
  • Score of 14 or less on the Beck Depression Inventory II (not depressed)
  • Study partner, defined as an informant/caregiver who has an average of 10 hours per week or more contact with participant and can accompany him/her to most study visits
  • Adequate visual and hearing acuity to allow testing
  • Women only: surgically sterile or 2 years postmenopausal
  • At least six grades of education or a good work history inside or outside the home
  • Fluent in English

Exclusion Criteria: 

  • Significant neurologic disease other than mild cognitive impairment (MCI), such as Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defects or known structural brain abnormalities
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body that preclude MRI examination
  • Psychiatric disorders, including major depression or bipolar disorder in the past 3 months, psychotic features, agitation or behavioral problems in the past 3 months that could lead to difficulty complying with the protocol, or history of schizophrenia
  • History of alcohol abuse or dependence in the past 2 years
  • Current significant systemic illness or unstable medical condition that could lead to difficulty complying with the protocol
  • Current conditions that may increase short-term risk from untreated obstructive sleep apnea: symptomatic coronary or cerebrovascular disease, as indicated by recent myocardial infarction or stroke (6 months); congestive heart failure; unstable angina; life-threatening arrhythmias; cardiomyopathy; transient ischemic attacks; and history of driving accidents related to daytime sleepiness
  • Participation in clinical studies involving neuropsychological measures being conducted more than twice a year or another clinical trial
  • Prohibited medications: Receiving CPAP or bilevel pressure for obstructive sleep apnea; need oxygen or bilevel pressure during CPAP titration polysomnography; regular use of bronchodilators or steroids; use of supplemental oxygen

Detailed Description: 

We are conducting a 6-month pilot clinical trial to compare the effects of active continuous positive airway pressure (CPAP) versus sham CPAP on cognitive and everyday function in 110 older adults with mild cognitive impairment (MCI) and obstructive sleep apnea. We also will collect pilot data on the 1-year outcomes of treatment of obstructive sleep apnea, and the validity of neuroimaging for measuring clinical change in people with MCI and obstructive sleep apnea. The results will inform the study design, sample size, participant recruitment and retention methods, and measures for a full-scale trial.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 40.1313817, -75.1370254

Abington Memorial Hospital
Abington
Pennsylvania
19001
Recruiting
Mary T. Hofmann, MD
215-481-4350
MHofmann@amh.org

Geolocation is 39.9583587, -75.1953934

University of Pennsylvania
Philadelphia
Pennsylvania
19104
Recruiting
Nalaka Gooneratne, MD
215-349-5938
ngoonera@mail.med.upenn.edu

Geolocation is 38.8454321, -77.3209555

George Mason University
Fairfax
Virginia
22030
Recruiting
Kathy C. Richards, PhD, RN
703-993-1962
kricha11@gmu.edu
Lead Sponsor: 
Agency
George Mason University
Collaborator Sponsor: 
Agency
National Institute on Aging (NIA)
Facility Investigators: 
NameRoleAffiliation
Kathy Richards, PhD, RN
Principal Investigator
George Mason University
Study Contact: 
NamePhoneEmail
Kathy Richards, PhD, RN
703-993-1961
Locations
 
 
ClinicalTrials.gov ID 
NCT01482351 (follow link to view full record on ct.gov in new window)
Official Title: 
Mild Cognitive Impairment and Obstructive Sleep Apnea
Study Start Date: 
February 2012
Study End Date: 
March 2014
Disease Stage: 
Early
Enrollment: 
110