NCT06089161

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Mar 2024May 2028

First Submitted

Initial submission to the registry

October 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 19, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

3.2 years

First QC Date

October 12, 2023

Last Update Submit

May 5, 2025

Conditions

Sleep Apnea

Outcome Measures

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).

    Up to 6 months

Secondary Outcomes (31)

  • Change in Molecular Biomarkers

    Baseline and 6 months

  • Change in Vascular Markers

    Baseline and 6 months

  • Change in Cardiometabolic Biomarkers measured in mg/dl

    Baseline and 6 months

  • Change in Cardiometabolic Biomarkers as measured in grams per deciliter

    Baseline and 6 months

  • Change in Cardiometabolic Biomarkers measured in mmol/mol

    Baseline and 6 months

  • +26 more secondary outcomes

Study Arms (2)

Standard of Care Group

ACTIVE COMPARATOR

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

Other: Standard of Care

Personalized OSA Treatment Group

EXPERIMENTAL

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

Other: Standard of CareBehavioral: Personalized OSA Treatment

Interventions

Standard of CareOTHER

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

Personalized OSA Treatment GroupStandard of Care Group
Personalized OSA TreatmentBEHAVIORAL

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.

Personalized OSA Treatment Group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Girardin Jean-Louis, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Girardin Jean-Louis, PhD

CONTACT

3052430776girardin.jean-louis@miami.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 18, 2023

Study Start

March 19, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

May 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)