Recruiting NCT06089161
Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care, Personalized OSA Treatment.
- Who it may be relevant to
- Registry conditions: Sleep Apnea. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- 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.
Primary outcome measures
- Proportion of participants adherence to OSA treatment [Time frame: Up to 6 months]
Secondary outcome measures (12)
- Change in Molecular Biomarkers [Time frame: Baseline and 6 months]
- Change in Vascular Markers [Time frame: Baseline and 6 months]
- Change in Cardiometabolic Biomarkers measured in mg/dl [Time frame: Baseline and 6 months]
- Change in Cardiometabolic Biomarkers as measured in grams per deciliter [Time frame: Baseline and 6 months]
- Change in Cardiometabolic Biomarkers measured in mmol/mol [Time frame: Baseline and 6 months]
- Change in Cardiometabolic Biomarkers- platelet count [Time frame: Baseline and 6 months]
- Change in Cardiometabolic Biomarkers as measured per microliter of Blood. [Time frame: Baseline and 6 months]
- Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre. [Time frame: Baseline and 6 months]
- Change in Cardiometabolic Biomarkers as measured milligrams per liter [Time frame: Baseline and 6 months]
- Change in Cardiometabolic Biomarkers Measured in microgram [Time frame: Baseline and 6 months]
- Change in Cardiometabolic Biomarkers Measured picograms per milliliter [Time frame: Baseline and 6 months]
- Change in NIH Toolbox -Oral Reading Recognition Test [Time frame: Baseline, 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT06089161 · 20220509 · 5R01AG075007-02