Recruiting

Personalized OSA Treatment

Sponsor:

University of Miami

Code:

NCT06089161

Conditions

Sleep Apnea

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard of Care

Personalized OSA Treatment

Study Details

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).

Conditions

Sleep Apnea

Study ID

NCT06089161

Start date

Mar 19, 2024

Status verified date

May, 2025

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Group

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

experimental: Personalized OSA Treatment Group

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

Interventions

Standard of Care

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

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 measure

  • Proportion of participants adherence to OSA treatment [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Girardin Jean-Louis, PhD

3052430776girardin.jean-louis@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Girardin Jean-Louis, PhD

3052430776girardin.jean-louis@miami.edu

More Information

Sponsor

University of Miami

Last update posted

May 8, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-05-08.