University of Miami to Lead $14 Million Study on Sleep Apnea Treatments

Girardin Jean-Louis, Ph.D., a professor at the Miller School and director of the Center for Translational Sleep and Circadian Sciences, is serving as a co-principal investigator alongside Sairam Parthasarathy, M.D., from the University of Arizona. The initiative also includes three additional clinical sites and a patient advocacy partner, focusing on generating evidence to assist patients, caregivers, and clinicians in making informed treatment choices.

Dr. Jean-Louis expressed the importance of providing effective, evidence-based sleep care, particularly in communities that face significant burdens from sleep disorders. He emphasized that OSA is common and frequently goes undertreated in many areas, including South Florida.

The trial, ADAPT-OSA, will utilize a three-arm, randomized clinical trial design, with each of the three treatment approaches enrolling 800 participants. The treatments being evaluated are:

1. Positive Airway Pressure (PAP) therapy, which provides a steady stream of pressurized air to keep the airway open during sleep.

2. Oral appliance therapy.

3. A combination of the medications atomoxetine and oxybutynin, which are employed to manage OSA.

Alexandre Rocha Abreu, M.D., an associate professor in the Division of Pulmonary, Critical Care, and Sleep Medicine at the Miller School, noted that this research will explore multiple treatment strategies in a pragmatic way, focusing on their effectiveness and patient acceptability.

Participants' sleep outcomes and other health metrics will be assessed at various intervals throughout the trial. The Miller School will play a vital role as one of the four sites for patient recruitment, employing a diverse outreach strategy. This approach includes community health worker partnerships, mobile clinics, health fairs, and targeted outreach efforts to enhance participation among underrepresented populations.

Dr. Jean-Louis has a notable background in enhancing community engagement in biomedical research and has highlighted how closely sleep disorders relate to chronic diseases and social determinants of health. He believes this trial addresses critical challenges in sleep medicine by aiming to pair the right therapy with the right patient, potentially moving away from a one-size-fits-all model to improve both treatment adherence and outcomes.

Henri Ford, M.D., M.H.A., dean of the Miller School, indicated that the trial's findings could significantly impact clinical practices in treating OSA.