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

ConditionSleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorUniversity of Miami

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Self-reported race/ethnicity as African American, African, Caribbean or black

Ages 60-85 years

accessible by phone

OSA diagnosis

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care

    Other intervention

    Participants in this group will receive standard of care treatment for sleep apnea.

  • Personalized OSA Treatment

    Behavioral

    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.

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: Standard of Care GroupActive comparator 1 intervention
Group B: Personalized OSA Treatment GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Up to 6 months

Secondary outcomes

1

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.

Time frame
Baseline and 6 months
2

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.

Time frame
Baseline and 6 months
3

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.

Time frame
Baseline and 6 months
4

Change in Cardiometabolic Biomarkers as measured in grams per deciliter

Hemoglobin, Albumin, and Total Protein. Measured in grams per deciliter assessed with blood analyses.

Time frame
Baseline and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

National Institute on Aging (NIA)

Collaborator