Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks

Study Overview
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Brief Summary
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The purpose of this research is to see how effective the Personalized obstructive sleep apnea (OSA) Treatment Adherence Model called PRAISE is in helping the patient stick to the physician recommended OSA treatment plan Positive Airway Pressure (PAP).

Official Title
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Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks

Conditions
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Sleep Apnea

Intervention / Treatment
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* Other: Standard of Care
* Behavioral: Personalized OSA Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported race/ethnicity as African American, African, Caribbean or black Ages 60-85 years accessible by phone OSA diagnosis consent, including permission to release medical data Exclusion Criteria: progressive illnesses in which disability or death is expected within 1 year impaired cognitive/ functional ability precluding participation intention to move within the year and a family member currently enrolled.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Group<br>Participants in this group receive the standard of care treatment for sleep apnea for up to six months. | Other: Standard of Care<br>* Participants in this group will receive standard of care treatment for sleep apnea.<br>|
| Experimental: Personalized OSA Treatment Group<br>Participants in this group receive personalized OSA treatment for sleep apnea for up to six months. | Other: Standard of Care<br>* Participants in this group will receive standard of care treatment for sleep apnea.<br>Behavioral: Personalized OSA Treatment<br>* Participants in this group will receive standard of care treatment plus the personalized treatment that consists of videos approximately three minutes long, virtual, accessed through web based application, that the participant watches weekly. The purpose of the video is tailored educational content for sleep apnea.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants adherence to OSA treatment | The proportion of participants who answer yes (meaning a participant acknowledges an average of more than 4 hours of continuous positive airway pressure use) or no (meaning a participant acknowledges an average of less than 4 hours of continuous positive airway pressure use). | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Molecular Biomarkers | The molecular biomarker are C₂N, Homocysteine, Neurofilament light, Glial fibrillary acidic protein, Tau, and Amyloid-Beta peptides and the inflammatory markers are Interleukin-6,Interleukin -10, and Tumor Necrosis Factor-alpha. All will be measured in picograms per milliliter. | Baseline and 6 months | 
| Change in Vascular Markers | Red Blood Cell Count, White Blood Cell Count, and Platelet Count will be measured. All will be measured in Cells/L. | Baseline and 6 months | 
| Change in Cardiometabolic Biomarkers measured in mg/dl | Total Cholesterol, HDL, LDL, Triglycerides, Bilirubin, Blood Urea Nitrogen (BUN), Calcium, Creatinine, and Glucose. Measured in milligrams/deciliter (mg/dl) assessed with blood analyses. | Baseline and 6 months | 
| Change in Cardiometabolic Biomarkers as measured in grams per deciliter | Hemoglobin, Albumin, and Total Protein. Measured in grams per deciliter assessed with blood analyses. | Baseline and 6 months | 
| Change in Cardiometabolic Biomarkers measured in mmol/mol | Glucose/HbA1C, Chloride, Potassium, Sodium, Homocysteine. Measured in mmol/mol assessed with blood analyses | Baseline and 6 months | 
| Change in Cardiometabolic Biomarkers- platelet count | Platelet Count. Measured per microliter of Blood. | Baseline and 6 months | 
| Change in Cardiometabolic Biomarkers as measured per microliter of Blood. | Blood Pressure. Measured per microliter of Blood. | Baseline and 6 months | 
| Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre. | Thyroid-stimulating hormone. Measured Milli-international units per litre. | Baseline and 6 months | 
| Change in Cardiometabolic Biomarkers as measured milligrams per liter | C-reactive protein Highly Sensitive. Measure milligrams per liter. | Baseline and 6 months | 
| Change in Cardiometabolic Biomarkers Measured in microgram | Folate. Measured microgram. | Baseline and 6 months | 
| Change in Cardiometabolic Biomarkers Measured picograms per milliliter | Vitamin B12. Measured picograms per milliliter. | Baseline and 6 months | 
| Change in NIH Toolbox -Oral Reading Recognition Test | An assessment of reading decoding skills and crystalized abilities. Participants are asked to read aloud letters and words, pronouncing the words as accurately as possible. | Baseline, 6 months | 
| Change in NIH Toolbox Picture Vocabulary Test | An assessment of receptive vocabulary administered in a computer-adaptive test (CAT) format. Participants must choose which of four pictures best represents a word presented via audio. | Baseline, 6 months | 
| Change in NIH Toolbox- Flanker Inhibitory Control and Attention | An assessment of inhibitory control and attention. The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it. This outcome will be reported as a composite score. | Baseline, 6 months | 
| Change in Executive Function measured by Dimensional Change Card Sort Test | Executive function, An assessment of cognitive flexibility and attention. The participant is asked to match a series of picture pairs to a target picture. | Baseline, 6 months | 
| Change in Episodic memory measured by Picture Sequence Memory Test | Episodic memory, An assessment of episodic memory. Participants are shown a number of activities, and then asked to reproduce the sequence of pictures as it was presented. | Baseline, 6 months | 
| Change in NIH Toolbox- Auditory Verbal Learning Test | Participants are given three trials to recall as many words as possible from a list of fifteen unrelated words. After a 5-25 minute delay, participants are asked to freely recall as many of the 15 words as possible.. | Baseline, 6 months | 
| Change in Working Memory measured by List Sorting Task | Working memory, An assessment of working memory. The participant is asked to recall and sequence different stimuli that are presented visually and via audio. | Baseline, 6 months | 
| Change in Processing Speed measured by Patten Comparison Processing Speed Test | Processing speed, An assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same. | Baseline, 6 months | 
| Change in Sustained attention measured by Psychomotor Vigilance Test | Sustained attention, The Psychomotor Vigilance Test (PVT) objectively assesses the mean response time to psychomotor vigilance tests during the Peak Alertness Window. | Baseline, 6 months | 
| Change in Neuropsychological Testing (Wechsler Test of Adult Reading | The test involves 50 incorrectly spelled words. The score is computed based on the number of correctly pronounced words. The scale ranges from 0-50, the higher the score the higher the reading ability. | Baseline, 6 months | 
| Change in Working Memory measured by Number Span Subset | In this test, the participant is asked to recall a series of numbers in reverse order. The correctly recalled series are scored as 1, and the test contains 14 sequences of numbers. The range of working memory score is from 0 to 14, with higher values representing better outcome. | Baseline, 6 months | 
| Change in Health-related quality of life | Patient-Reported Outcomes Measurement Information System Short Form v1.1 - Global Health (5. Excellent, 4. Very good, 3. Good, 2. Fair, 1. Poor) Higher score indicates better self-reported health-related quality of life | Baseline, 2 months, 6 months | 
| Change in Daytime functioning | Patient-Reported Outcomes Measurement Information System Short form v1.0 Sleep-Related Impairment 8a (1. Not at all 2. A little bit 3. Somewhat 4. Quite a bit 5. Very much) A lower score indicates better daytime functioning | Baseline, 2 months, 6 months | 
| Changes in Sleep Quality measured by Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance | Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance 4a (1. Not at all 2. A little bit 3. Somewhat 4. Quite a bit 5. Very much) | Baseline, 2 months, 6 months | 
| Changes in number of minutes as measured by FitBit Sleep Stages | Sleep quality will be measured by the number of minutes by FitBit Sleep Stages. | Baseline, 2 months, 6 months | 
| Changes in Sleep quality measured by Sleep Score | FitBit Sleep score Min: 1 Max: 100 Excellent: 90-100 Good: 80-89 Fair: 60-79 Poor: Less than 60 | Baseline, 2 months, 6 months | 
| Change in Cardiometabolic Biomarkers as measured in percentage | Hematocrit. Measured as a percentage. | Baseline and 6 months |