Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks
- Conditions
- Sleep Apnea
- Interventions
- Other: Standard of CareBehavioral: Personalized OSA Treatment
- Registration Number
- NCT06089161
- Lead Sponsor
- University of Miami
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 330
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Group Standard of Care Participants in this group receive the standard of care treatment for sleep apnea for up to six months. Personalized OSA Treatment Group Standard of Care Participants in this group receive personalized OSA treatment for sleep apnea for up to six months. Personalized OSA Treatment Group Personalized OSA Treatment Participants in this group receive personalized OSA treatment for sleep apnea for up to six months.
- Primary Outcome Measures
Name Time Method Proportion of participants adherence to OSA treatment Up to 6 months 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).
- Secondary Outcome Measures
Name Time Method Change in Cardiometabolic Biomarkers as measured in grams per deciliter Baseline and 6 months Hemoglobin, Albumin, and Total Protein. Measured in grams per deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre. Baseline and 6 months Thyroid-stimulating hormone. Measured Milli-international units per litre.
Change in Cardiometabolic Biomarkers Measured in microgram Baseline and 6 months Folate. Measured microgram.
Change in Vascular Markers Baseline and 6 months Red Blood Cell Count, White Blood Cell Count, and Platelet Count will be measured. All will be measured in Cells/L.
Change in Cardiometabolic Biomarkers measured in mmol/mol Baseline and 6 months Glucose/HbA1C, Chloride, Potassium, Sodium, Homocysteine. Measured in mmol/mol assessed with blood analyses
Change in Molecular Biomarkers Baseline and 6 months 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.
Change in Cardiometabolic Biomarkers- platelet count Baseline and 6 months Platelet Count. Measured per microliter of Blood.
Change in Sleep Awakening measured by Fitbit Baseline, 2 months Number of awakenings
Change in Cardiometabolic Biomarkers as measured per microliter of Blood. Baseline and 6 months Blood Pressure. Measured per microliter of Blood.
Change in Cardiometabolic Biomarkers as measured milligrams per liter Baseline and 6 months C-reactive protein Highly Sensitive. Measure milligrams per liter.
Change in Executive Function measured by Dimensional Change Card Sort Test Baseline, 6 months Executive function, An assessment of cognitive flexibility and attention. The participant is asked to match a series of picture pairs to a target picture.
Change in Health-related quality of life Baseline, 2 months, 6 months 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
Change in Cardiometabolic Biomarkers measured in mg/dl Baseline and 6 months Total Cholesterol, HDL, LDL, Triglycerides, Bilirubin, Blood Urea Nitrogen (BUN), Calcium, Creatinine, and Glucose. Measured in milligrams/deciliter (mg/dl) assessed with blood analyses.
Change in NIH Toolbox -Oral Reading Recognition Test Baseline, 6 months 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.
Change in Episodic memory measured by Picture Sequence Memory Test Baseline, 6 months 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.
Change in Processing Speed measured by Patten Comparison Processing Speed Test Baseline, 6 months Processing speed, An assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same.
Changes in number of minutes as measured by FitBit Sleep Stages Baseline, 2 months, 6 months Sleep quality will be measured by the number of minutes by FitBit Sleep Stages.
Change in the number of floors climbed measured by Fitbit Baseline, 2 months Number of floors climbed
Change in Cardiometabolic Biomarkers Measured picograms per milliliter Baseline and 6 months Vitamin B12. Measured picograms per milliliter.
Change in NIH Toolbox Picture Vocabulary Test Baseline, 6 months 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.
Change in NIH Toolbox- Flanker Inhibitory Control and Attention Baseline, 6 months 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.
Change in Working Memory measured by List Sorting Task Baseline, 6 months Working memory, An assessment of working memory. The participant is asked to recall and sequence different stimuli that are presented visually and via audio.
Change in Working Memory measured by Number Span Subset Baseline, 6 months 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.
Change in Daytime functioning Baseline, 2 months, 6 months 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
Changes in Sleep Quality measured by Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance Baseline, 2 months, 6 months 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)
Changes in Sleep quality measured by Sleep Score Baseline, 2 months, 6 months FitBit Sleep score:
Excellent: 90 to 100 Good: 80 to 89 Fair: 60 to 79 Poor: less than 60 Min: 1 Max: 100 Excellent: 90-100 Good: 80-89 Fair: 60-79 Poor: Less than 60Change in Cardiometabolic Biomarkers as measured in percentage Baseline and 6 months Hematocrit. Measured as a percentage.
Change in number of calories burned measured by FitBit Baseline, 2 months, 6 months Number of Calories burned
Change in NIH Toolbox- Auditory Verbal Learning Test Baseline, 6 months 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..
Change in distance traveled measured in Miles by Fitbit Baseline, 2 months distance traveled measured by mile
Change in number of steps taken measured by Fitbit Baseline, 2 months number of steps taken
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States