Miller School of Medicine Co‑Leads $14 Million PCORI Trial to Transform Sleep Apnea Care

By: Staff Writer | May 11, 2026 | 7 min. read |

A five‑year, multisite clinical trial will compare three patient‑centered treatment strategies for obstructive sleep apnea, enrolling 2,400 participants nationwide.

Dr. Azizi Seixas, in a white shirt and black coat

Nearly a billion adults worldwide and more than 80 million in the United States aren’t getting the sleep they need due to obstructive sleep apnea.

The University of Miami Miller School of Medicine is playing a prominent role in finding a solution.

Girardin Jean-Louis, Ph.D., professor of psychiatry and behavioral sciences and neurology and director of the Center for Translational Sleep and Circadian Sciences at the Miller School, is co-principal investigator of a major new study funded by the Patient-Centered Outcomes Research Institute (PCORI). A $14 million grant funds ADAPT-OSA, an investigation into the comparative effectiveness of three treatment approaches for obstructive sleep apnea (OSA).

Dr. Jean-Louis, director of the PRIDE Institute in Behavioral Medicine and Sleep Disorders Research, will co-lead the study with Sairam Parthasarathy, M.D., from the University of Arizona. The study also includes three additional clinical enrollment sites and a patient advocacy partner, with the broader goal of generating evidence that helps patients, caregivers and clinicians make more informed treatment decisions.

A Landmark, Patient‑Centered Trial for Obstructive Sleep Apnea

For Dr. Jean-Louis, the study reflects a longstanding scientific and public health commitment to improve access to effective, evidence-based sleep care for the communities most burdened by sleep disorders and their consequences.

Dr. Girardin Jean-Louis in dark suit — Dr. Girardin Jean-Louis is co-leading a study investigating patient-centered approaches to obstructive sleep apnea.

“Obstructive sleep apnea is common, consequential and still undertreated in many communities,” said Dr. Jean-Louis. “This study gives us an opportunity to test treatment strategies in real-world settings and to do so in a way that is scientifically rigorous and patient-centered.”

“Obstructive sleep apnea is underdiagnosed and poorly treated in communities of South Florida,” said Edilin Edgecomb, M.D., a researcher at the Miller School. “At the University of Miami, we have the infrastructure, stakeholder-engaged support and expertise to generate evidence that is both rigorous and relevant. ADAPT-OSA is the kind of patient-centered research that can meaningfully change how sleep apnea is treated across our region.”

Comparing Three Real‑World Treatments for Sleep Apnea

The five-year study is a three-arm, randomized clinical trial that will enroll 2,400 participants across sites, with 800 participants in each treatment arm. Participants will be randomized to receive:

• Positive Airway Pressure (PAP) therapy, during which a steady stream of pressurized air is delivered through a mask to keep the airway open during sleep

• Oral appliance therapy

• A combination of atomoxetine and oxybutynin, medications used to control obstructive sleep apnea

“By evaluating multiple therapeutic strategies within a pragmatic framework, we will be better equipped to identify approaches that are clinically effective and patient-centered, prioritizing acceptability, long-term adherence and real-world feasibility,” said Alexandre Rocha Abreu, M.D., associate professor in the Division of Pulmonary, Critical Care and Sleep Medicine at the Miller School.

Researchers will assess sleep outcomes and other patient-centered outcomes at baseline and at three, six, nine and 12-month touchpoints. The Miller School will serve as one of four patient recruitment sites.

Landscape infographic titled “Obstructive Sleep Apnea (OSA) in the U.S.” in University of Miami orange and green. Text states that more than 83.7 million U.S. adults ages 20 and older have obstructive sleep apnea, and that up to 80% of people with the condition are undiagnosed. A stylized U.S. map icon represents prevalence, a circular chart highlights the 80% figure, and a row of icons illustrates symptoms including loud snoring, breathing pauses, excessive daytime sleepiness, and restless sleep.

Miller School Experts Advancing Community‑Engaged Sleep Research

A distinguishing feature of the study is its emphasis on broad and meaningful participation. Recruitment will extend beyond traditional clinic pathways to include community-facing strategies such as partnerships with Community Engagement Alliance programs and community health workers, mobile health units, health fairs, one-on-one outreach and rural health initiatives. Clinic-based recruitment will also include HIPAA-compliant electronic health record queries, physician referrals and outreach in primary care, women’s health and sleep medicine clinics.

This recruitment model reflects an area in which Dr. Jean-Louis has been especially influential: building stakeholder-engaged, community-responsive research infrastructures that invite participation in biomedical research.

As a leader in sleep health research, he has spent much of his career demonstrating how sleep disorders intersect with chronic disease and social determinants of health. His work has consistently demonstrated that medical evidence is strongest when the populations represented in research resemble the populations seen in practice.

“This trial has real clinical significance because it addresses one of the central challenges in sleep medicine: matching the right therapy to the right patient. The findings could help clinicians move beyond a one-size-fits-all approach and improve both adherence and long-term outcomes,” said Henri Ford, M.D., M.H.A., dean and chief academic officer at the Miller School.