Mild Cognitive Impairment and Obstructive Sleep Apnea (MEMORIES)
|ClinicalTrials.gov Identifier: NCT01482351|
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Mild Cognitive Impairment||Device: Continuous Positive Airway Pressure [CPAP]||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mild Cognitive Impairment and Obstructive Sleep Apnea|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Continuous Positive Airway Pressure
Participants diagnosed with OSA who choose to treat their apnea with Continuous Positive Airway Pressure (CPAP) will be compared with those who do not choose to use CPAP and no-apnea controls at 1 year to assess changes in mild cognitive impairment.
Device: Continuous Positive Airway Pressure [CPAP]
Study participants with sleep apnea will choose to use or not use a continuous positive airway pressure (CPAP) machine to treat their apnea after a consultation with their doctor. Dosage of CPAP will be individually determined using standardized methods in an overnight CPAP titration polysomnography.
- Hopkins Verbal Learning Test-Revised [HVLT-R] [ Time Frame: Change from baseline at 6 months and 1 year ]Memory (immediate and delayed recall) will be assessed using HVLT-R. HVLT-R has been used in elders with Alzheimer's Disease and takes 10 minutes to complete. We will use 6 alternative forms. Forms 1, 2, and 4 will be used for half the participants and forms 3, 5 and 6 will be used for the rest of the participants.
- Everyday Cognition [E-Cog] [ Time Frame: Change from baseline at 6 months and 1 year ]Cognitively mediated functional abilities will be assessed using E-Cog. It is a study-partner rated 39-item questionnaire.
- Digit Symbol-Coding [DSC] [ Time Frame: Change from baseline at 6 months and 1 year ]Psychomotor/cognitive processing speed will be assessed using the DSC subtest from the Wechsler Adult Intelligence Test (WAIS-III).
- Mini Mental State Exam (MMSE) [ Time Frame: Change from baseline at 6 months and 1 year ]Global cognitive function will be assessed using MMSE. It is a 30-item cognitive screen measuring orientation, registration, short-term memory, attention/concentration, language, and constructional capacity. Summary score will be used as a measure of global cognitive function. It takes about 5 minutes to complete.
- Stroop Color and Word Test [SCW] [ Time Frame: Change from baseline at 6 months and 1 year ]Attention will be measured using SCW. We will use the Golden format, which is sensitive to age-related declines in processing speed. The SCW has been used in elders with Alzheimer's Disease and it takes about 30 minutes to complete.
- The Psychomotor Vigilance Task (PVT) [ Time Frame: Change from baseline at 6 months and 1 year ]Attention/reaction time will assessed using the PVT. PVT has been used in elders with Alzheimer's Disease and requires about 30 minutes to complete.
- Epworth Sleepiness Scale [ESS] [ Time Frame: Change from baseline at 6 months and 1 year ]Daytime sleepiness be assessed using ESS. The ESS asks the respondent to rate the likelihood of falling asleep in eight specific situations using a four-point Likert scale ranging from never dozing to high chance of dozing. The scale significantly correlates with the frequency of apneas and is a clinical and research standard for the assessment of daytime sleepiness. Persons with cognitive impairment are able to complete the scale. It requires 5 minutes to complete.
- Functional Outcomes Sleep Questionnaire [FOSQ] [ Time Frame: Change from baseline at 6 months and 1 year ]Everyday function will be assessed using FOSQ. It is a 30-item Likert-scale, self-report, disease-specific functional status measure written at the 4th grade level.
- Alzheimer's Disease Cooperative Study - Clinicians' Global Impression of Change Scale [ADCS-CGIC] [ Time Frame: Change from baseline at 1 year ]Global change (progression) will be assessed using ADCS-CGIC at 1 year. It can be completed at home by participants or their study partners. It is sensitive to small differences in several domains that may add up to a clinically meaningful change.
- Clinical Dementia Rating Scale [CDR] [ Time Frame: Change from baseline at 1 year ]Cognitive ability will be assessed and staged using CDR. It uses a structured interview takes 60-90 minutes to complete. The CDR will be completed by the graduate assistant with input from the geriatrician and neuropsychologist.
- Neuroimaging Biomarker: Hippocampal Volume [ Time Frame: Change in hippocampal volume between baseline and 1 year follow-up magnetic resonance imaging scan. ]Change in hippocampal volume between baseline and 1 year follow-up scan (atrophy) will be quantified automatically using unbiased registration between 2 time points. Structural and calibration scans used in this protocol have been adopted from the Alzheimer's Disease Neuroimaging Initiative [ADNI] protocol.
- Neuroimaging Biomarker: Regional Brain Volume and Thickness. [ Time Frame: Change in regional brain volume and thickness between baseline and 1 year follow-up magnetic resonance imaging scan. ]Structural effects of CPAP outside of the hippocampus will be measured using FreeSurfer software to automatically estimate hemispheric and lobar cortical thickness; cortical and subcortical gray matter volume; white matter volume; and ventricular volume. The FreeSurfer longitudinal module will be used to estimate change in these measures.
- Neuroimaging Biomarker: Hippocampal Subfield Volumes. [ Time Frame: Change in hippocampal subfield volume between baseline and 1 year follow-up magnetic resonance imaging scan ]We will perform automatic segmentation of hippocampal subfields in the baseline T2-weighted turbo spin echo [TSE] images. This will estimate volumes of subfields CA1, CA2, CA3, dentate gyrus, subiculum, and entorhinal cortex. We will then quantify longitudinal change in subfield volumes using the approach for the whole hippocampus, modified to account for anisotropic voxel size in TSE images.
- Neuroimaging Biomarker: Ischemic Lesion Volume. [ Time Frame: Change in ischemic lesion volume between baseline and 1 year follow-up magnetic resonance imaging scan ]The volume of white matter hyperintensity (leuokoaraiosis) will be assessed in CSFsuppressed T2-weighted (FLAIR) structural MRI. A semi-automated intensity-based segmentation technique will be used to identify cortical and subcortical strokes as well as ischemic lesions in subcortical white matter considered to be the sequelae of hypoperfusion.
- Neuroimaging Biomarker: Cerebral Blood Flow. [ Time Frame: Change in cerebral blood flow between baseline and 1 year follow-up magnetic resonance imaging scan ]ASL perfusion MRI provides regional cerebral blood flow (rCBF) in absolute units of ml/100g/min. Arterial Spin Labeling [ASL] signal processing will follow established procedures in our laboratory using the ASL data processing toolbox (ASL tbx). CBF will then be quantified within cortical gray matter, hippocampal gray matter, and white matter regions based on FreeSurfer templates.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482351
|United States, Pennsylvania|
|Abington Memorial Hospital|
|Abington, Pennsylvania, United States, 19001|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Virginia|
|George Mason University|
|Fairfax, Virginia, United States, 22030|
|Principal Investigator:||Kathy Richards, PhD, RN||George Mason University|