Clinical trial NCT06089161: Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks
Official title: Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-10-18
Enrollment: 330
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


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.

Primary outcomes:
measure: Proportion of participants adherence to OSA treatment
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in Molecular Biomarkers
timeFrame: Baseline and 6 months
measure: Change in Vascular Markers
timeFrame: Baseline and 6 months
measure: Change in Cardiometabolic Biomarkers measured in mg/dl
timeFrame: Baseline and 6 months
measure: Change in Cardiometabolic Biomarkers as measured in grams per deciliter
timeFrame: Baseline and 6 months
measure: Change in Cardiometabolic Biomarkers measured in mmol/mol
timeFrame: Baseline and 6 months
measure: Change in Cardiometabolic Biomarkers- platelet count
timeFrame: Baseline and 6 months
measure: Change in Cardiometabolic Biomarkers as measured per microliter of Blood.
timeFrame: Baseline and 6 months
measure: Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre.
timeFrame: Baseline and 6 months
measure: Change in Cardiometabolic Biomarkers as measured milligrams per liter
timeFrame: Baseline and 6 months
measure: Change in Cardiometabolic Biomarkers Measured in microgram
timeFrame: Baseline and 6 months
measure: Change in Cardiometabolic Biomarkers Measured picograms per milliliter
timeFrame: Baseline and 6 months
measure: Change in NIH Toolbox -Oral Reading Recognition Test
timeFrame: Baseline, 6 months
measure: Change in NIH Toolbox Picture Vocabulary Test
timeFrame: Baseline, 6 months
measure: Change in NIH Toolbox- Flanker Inhibitory Control and Attention
timeFrame: Baseline, 6 months
measure: Change in Executive Function measured by Dimensional Change Card Sort Test
timeFrame: Baseline, 6 months
measure: Change in Episodic memory measured by Picture Sequence Memory Test
timeFrame: Baseline, 6 months
measure: Change in NIH Toolbox- Auditory Verbal Learning Test
timeFrame: Baseline, 6 months
measure: Change in Working Memory measured by List Sorting Task
timeFrame: Baseline, 6 months
measure: Change in Processing Speed measured by Patten Comparison Processing Speed Test
timeFrame: Baseline, 6 months
measure: Change in Working Memory measured by Number Span Subset
timeFrame: Baseline, 6 months
measure: Change in Health-related quality of life
timeFrame: Baseline, 2 months, 6 months
measure: Change in Daytime functioning
timeFrame: Baseline, 2 months, 6 months
measure: Changes in Sleep Quality measured by Patient-Reported Outcomes Measurement Information System Short Form v1.0 Sleep Disturbance
timeFrame: Baseline, 2 months, 6 months
measure: Changes in number of minutes as measured by FitBit Sleep Stages
timeFrame: Baseline, 2 months, 6 months
measure: Changes in Sleep quality measured by Sleep Score
timeFrame: Baseline, 2 months, 6 months
measure: Change in Cardiometabolic Biomarkers as measured in percentage
timeFrame: Baseline and 6 months
measure: Change in number of calories burned measured by FitBit
timeFrame: Baseline, 2 months, 6 months
measure: Change in the number of floors climbed measured by Fitbit
timeFrame: Baseline, 2 months
measure: Change in distance traveled measured in Miles by Fitbit
timeFrame: Baseline, 2 months
measure: Change in number of steps taken measured by Fitbit
timeFrame: Baseline, 2 months
measure: Change in Sleep Awakening measured by Fitbit
timeFrame: Baseline, 2 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Girardin Jean-Louis, PhD
role: PRINCIPAL_INVESTIGATOR
References: