Mild Cognitive Impairment and Obstructive Sleep Apnea (MEMORIES)
Mild Cognitive Impairment and Obstructive Sleep Apnea (MEMORIES)
Overall Status:
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 Age | Max Age | Gender | Healthy 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 | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 40.1313817, -75.1370254 | Abington Memorial Hospital | Abington | Pennsylvania | 19001 | Recruiting | |
Geolocation is 39.9583587, -75.1953934 | University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting | |
Geolocation is 38.8454321, -77.3209555 | George Mason University | Fairfax | Virginia | 22030 | Recruiting |
Lead Sponsor:
| Agency |
|---|
George Mason University |
Collaborator Sponsor:
| Agency |
|---|
National Institute on Aging (NIA) |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Kathy Richards, PhD, RN | Principal Investigator | George Mason University |
Study Contact:
| Name | Phone | |
|---|---|---|
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
