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

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).

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea
• Intervention / Treatment: Other: Standard of Care; Behavioral: Personalized OSA Treatment

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Girardin Jean-Louis, PhD; Phone Number: 3052430776; Email: girardin.jean-louis@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Girardin Jean-Louis, PhD; Phone Number: 3052430776; Email: girardin.jean-louis@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care Group; Participants in this group receive the standard of care treatment for sleep apnea for up to six months.	Other: Standard of Care; Participants in this group will receive standard of care treatment for sleep apnea.
Experimental: Personalized OSA Treatment Group; Participants in this group receive personalized OSA treatment for sleep apnea for up to six months.	Other: Standard of Care; Participants in this group will receive standard of care treatment for sleep apnea.; Behavioral: Personalized OSA Treatment; 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.

What is the study measuring?

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 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
Change in Cardiometabolic Biomarkers as measured in percentage	Hematocrit. Measured as a percentage.	Baseline and 6 months
Changes in Sleep quality measured by Sleep Score	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 60	Baseline, 2 months, 6 months
Change in number of calories burned measured by FitBit	Number of Calories burned	Baseline, 2 months, 6 months
Change in the number of floors climbed measured by Fitbit	Number of floors climbed	Baseline, 2 months
Change in distance traveled measured in Miles by Fitbit	distance traveled measured by mile	Baseline, 2 months
Change in number of steps taken measured by Fitbit	number of steps taken	Baseline, 2 months
Change in Sleep Awakening measured by Fitbit	Number of awakenings	Baseline, 2 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Girardin Jean-Louis, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Respiratory Tract Diseases; Neurocognitive Disorders; Respiration Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Alzheimer Disease; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 20220509; 5R01AG075007-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No