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

University of Miami

Status: Enrolling

Conditions: Sleep Apnea

Treatments: Other: Standard of Care; Behavioral: Personalized OSA Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06089161

20220509

5R01AG075007-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 330 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 2 patient groups

Standard of Care Group

Active Comparator group

Description:

Participants in this group receive the standard of care treatment for sleep apnea for up to six months.

Treatment:

Other: Standard of Care

Personalized OSA Treatment Group

Experimental group

Description:

Participants in this group receive personalized OSA treatment for sleep apnea for up to six months.

Treatment:

Behavioral: Personalized OSA Treatment

Other: Standard of Care