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

NCT ID: NCT06089161

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-19

Study Completion Date

2028-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard of Care Group

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

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

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

Personalized OSA Treatment Group

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

Group Type EXPERIMENTAL

Standard of Care

Intervention Type OTHER

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

Personalized OSA Treatment

Intervention Type 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.

Interventions

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Standard of Care

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

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Girardin Jean-Louis

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Girardin Jean-Louis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Girardin Jean-Louis, PhD

Role: CONTACT

3052430776

Facility Contacts

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Girardin Jean-Louis, PhD

Role: primary

3052430776

Other Identifiers

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5R01AG075007-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20220509

Identifier Type: -

Identifier Source: org_study_id

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