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

University of Miami1 site in 1 country330 target enrollmentMarch 19, 2024

ConditionsSleep Apnea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Apnea
Sponsor: University of Miami
Enrollment: 330
Locations: 1
Primary Endpoint: Proportion of participants adherence to OSA treatment
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 19, 2024

End Date

May 31, 2028

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Girardin Jean-Louis

Distinguished Professor

University of Miami

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Proportion of participants adherence to OSA treatment

Time Frame: 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 Outcomes

Change in Cardiometabolic Biomarkers as measured in grams per deciliter(Baseline and 6 months)
Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre.(Baseline and 6 months)
Change in Cardiometabolic Biomarkers Measured in microgram(Baseline and 6 months)
Change in Vascular Markers(Baseline and 6 months)
Change in Cardiometabolic Biomarkers measured in mmol/mol(Baseline and 6 months)
Change in Molecular Biomarkers(Baseline and 6 months)
Change in Cardiometabolic Biomarkers- platelet count(Baseline and 6 months)
Change in Sleep Awakening measured by Fitbit(Baseline, 2 months)
Change in Cardiometabolic Biomarkers as measured per microliter of Blood.(Baseline and 6 months)
Change in Cardiometabolic Biomarkers as measured milligrams per liter(Baseline and 6 months)
Change in Executive Function measured by Dimensional Change Card Sort Test(Baseline, 6 months)
Change in Health-related quality of life(Baseline, 2 months, 6 months)
Change in Cardiometabolic Biomarkers measured in mg/dl(Baseline and 6 months)
Change in NIH Toolbox -Oral Reading Recognition Test(Baseline, 6 months)
Change in Episodic memory measured by Picture Sequence Memory Test(Baseline, 6 months)
Change in Processing Speed measured by Patten Comparison Processing Speed Test(Baseline, 6 months)
Changes in number of minutes as measured by FitBit Sleep Stages(Baseline, 2 months, 6 months)
Change in the number of floors climbed measured by Fitbit(Baseline, 2 months)
Change in Cardiometabolic Biomarkers Measured picograms per milliliter(Baseline and 6 months)
Change in NIH Toolbox Picture Vocabulary Test(Baseline, 6 months)
Change in NIH Toolbox- Flanker Inhibitory Control and Attention(Baseline, 6 months)
Change in Working Memory measured by List Sorting Task(Baseline, 6 months)
Change in Working Memory measured by Number Span Subset(Baseline, 6 months)
Change in 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(Baseline, 2 months, 6 months)
Changes in Sleep quality measured by Sleep Score(Baseline, 2 months, 6 months)
Change in Cardiometabolic Biomarkers as measured in percentage(Baseline and 6 months)
Change in number of calories burned measured by FitBit(Baseline, 2 months, 6 months)
Change in NIH Toolbox- Auditory Verbal Learning Test(Baseline, 6 months)
Change in distance traveled measured in Miles by Fitbit(Baseline, 2 months)
Change in number of steps taken measured by Fitbit(Baseline, 2 months)