Mild Cognitive Impairment and Obstructive Sleep Apnea



Status:Completed
Conditions:Cognitive Studies, Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:55 - 89
Updated:3/8/2019
Start Date:September 2012
End Date:December 2014

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Obstructive sleep apnea (OSA) has been linked to increased risk for Alzheimer's disease (AD),
but little prospective evidence exists on the effects of OSA treatment in preclinical AD. The
objective was to determine if CPAP treatment adherence, controlling for baseline differences,
predicts cognitive and everyday function after 1 year in older adults with MCI and to
determine effect sizes for a larger trial. The aim of the Mild Cognitive Impairment and
Obstructive Sleep Apnea (Memories 1) trial was to determine whether CPAP treatment adherence,
controlling for any baseline differences in OSA severity, ApoE4, and other previously
identified demographic and patient factors, might predict cognitive and everyday function
after 1 year in older adults with amnestic MCI.

In this prospective open label clinical trial, primary inclusions were age 55-89 years and
apnea-hypopnea index ≥ 10. Groups were: (1) MCI, OSA, and CPAP adherent (MCI+CPAP); (2) MCI,
OSA, CPAP nonadherent(MCI-CPAP). There were 68 MCI+OSA participants at baseline, and 14 (21%)
dropped out during the 1 year follow-up. At 1 year, n=54, with MCI+CPAP group n=29, and
MCI-CPAP group n=25. Statistically significant improvements in psychomotor/cognitive
processing speed in the MCI+CPAP group versus the MCI-CPAP group were observed at 1 year
after adjustment for age, race, and marital status. There were small to moderate effect sizes
(ES) for memory, attention, daytime sleepiness, and everyday function, favoring the MCI+CPAP
group versus the MCI-CPAP group.

Inclusion criteria

Participants are included in the study if all of the following criteria are met:

(1) Are able to provide written informed consent by self or legally authorized
representative. MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) will
be used to assess decision making capacity; (2) OSA defined as an apnea-hypopnea index
(AHI) ≥10, using either a clinical split- or whole-night polysomnography. We chose an AHI
cut-off of ≥10 as opposed to ≥15, the conventional cut-off for moderate OSA because
split-night studies underestimate the AHI; (3) education-adjusted scores of 28-35 on the
modified Telephone Interview for Cognitive Status; (4) 0-0.5 on the Clinical Dementia
Rating (CDR); (5) 24-30 on the Mini-Mental State Examination (MMSE); (6) memory impairment
approximately 1.0-1.5 standard deviations below normal (adjusted for age and education),
determined by scores on the Logical Memory II test; (7) performance approximately 1.0-1.5
standard deviations below normal (adjusted for age and education) in no more than one
cognitive domain in addition to memory; (8) medications stable for at least 4 weeks;
washout from psychoactive medications (e.g., excluded anti-depressants, neuroleptics,
chronic anxiolytics, and sedative hypnotics) for 4 weeks; (9) score of ≤28 on the 21-item
Beck Depression Inventory II; (10) a study partner who spends at least 10 hours per week in
phone or in-person contact with participant; (11) visual and auditory acuity for testing;
(12) 6 or more grades of education completed, or a history to exclude intellectual
disability; and (13) English fluency.

Exclusion criteria

Patients are excluded from participating in this study if 1 or more of the following
criteria are met:

(1) significant neurologic disease other than MCI; (2) MRI exclusions, e.g. metal; (3)
psychiatric disorders, including uncontrolled major depression, bipolar disorder, or
schizophrenia; (4) history of alcohol dependence within 6 months; (5) current significant
unstable medical condition; (6) participation in studies involving neuropsychological
testing; (7) currently receiving CPAP; (8) requiring oxygen during CPAP; (9) dementia
indicated by impairment in 3-5 age and education adjusted cognitive domains.
We found this trial at
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Fairfax, Virginia 22030
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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