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Behavioural Intervention

Personalized Treatment for Obstructive Sleep Apnea (PRAISE Trial)

N/A
Recruiting
Led By Girardin Jean-Louis, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 60-85 years
OSA diagnosis
Must not have
Impaired cognitive/functional ability precluding participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 months, 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a model to help people stick to their sleep apnea treatment plan, to improve their long-term health.

Who is the study for?
This trial is for African American, African, Caribbean or black individuals aged 60-85 with obstructive sleep apnea (OSA). Participants must be reachable by phone and give consent to release medical data. It's not for those planning to move soon, with terminal illnesses, or cognitive impairments that prevent participation.
What is being tested?
The study tests the PRAISE model's effectiveness in improving adherence to Positive Airway Pressure (PAP) treatment for OSA. It compares standard care against a personalized approach to see if it can better manage OSA and impact Alzheimer’s disease biomarkers and cognition.
What are the potential side effects?
While the trial primarily focuses on treatment adherence rather than medication side effects, using PAP machines may cause discomfort like nasal congestion, dry mouth, skin irritation from masks or straps, and sometimes claustrophobia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 60 and 85 years old.
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I have been diagnosed with obstructive sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am mentally and physically able to participate in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants adherence to OSA treatment
Secondary study objectives
Change in Cardiometabolic Biomarkers Measured in microgram
Change in Cardiometabolic Biomarkers Measured picograms per milliliter
Change in Cardiometabolic Biomarkers as measured by Milli-international units per litre.
+28 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized OSA Treatment GroupExperimental Treatment2 Interventions
Participants in this group receive personalized OSA treatment for sleep apnea for up to six months.
Group II: Standard of Care GroupActive Control1 Intervention
Participants in this group receive the standard of care treatment for sleep apnea for up to six months.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
949 Previous Clinical Trials
428,127 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,002 Total Patients Enrolled
4 Trials studying Sleep Apnea
824 Patients Enrolled for Sleep Apnea
Girardin Jean-Louis, PhDPrincipal InvestigatorUniversity of Miami
4 Previous Clinical Trials
606 Total Patients Enrolled
~220 spots leftby May 2027
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