Five-Year, 2,400-Patient Multi-Center Study to Generate First Comprehensive Head-to-Head Evidence on CPAP, Oral Appliance Therapy, and Pharmacological Treatment; Daybreak to Support OAT Access for Study Participants

LOS ANGELES, June 12, 2026 /PRNewswire/ -- The University of Arizona has announced a landmark clinical trial that will deliver the most comprehensive head-to-head comparison of the three leading obstructive sleep apnea (OSA) treatments to date. Funded by a five-year, nearly $14 million award from the Patient-Centered Outcomes Research Institute (PCORI), the study will enroll 2,400 patients across four major academic medical centers to help patients and physicians make better-informed OSA treatment decisions.

Led by Dr. Sairam Parthasarathy, Director of the University of Arizona Center for Sleep, Circadian & Neuroscience Research, the trial will compare CPAP therapy, a mandibular advancement device (MAD), and a pharmacological combination of atomoxetine and oxybutynin. Participants will be followed for 12 months across measures including daytime sleepiness, blood pressure, quality of life, and treatment adherence. Study sites include the University of Arizona (primary), Stanford Medicine, the University of Maryland School of Medicine, and the University of Miami Miller School of Medicine.

"Access remains one of the biggest challenges in sleep medicine today. Daybreak's ability to streamline the path from diagnosis to treatment while preserving appropriate clinical oversight made them a compelling partner for this research." - Dr. Sairam Parthasarathy

Daybreak's direct-to-patient delivery model and clinical support infrastructure were identified as a practical solution to many of the barriers that commonly impact OAT treatment access, adherence, and continuity of care in large-scale, nationwide clinical research. As part of the collaboration, Daybreak will provide its FDA-cleared MAD therapy and patient support services to OAT study subjects across all four trial participating sites.

Daybreak's nationwide care model is uniquely positioned to deliver a highly standardized treatment experience across geographically diverse patient populations. Study subjects across all sites receive uniform onboarding process, treatment protocol, follow-up cadence, and clinical support infrastructure that supports retention. This model helps reduce operational variability while maintaining a consistent, high standard of care throughout the study.

"This study has the potential to reshape how patients and physicians approach sleep apnea treatment for years to come. We are honored that Daybreak can contribute to that work by ensuring participants in the oral appliance therapy arm have reliable, consistent access to treatment throughout the study. We are grateful to Dr. Parthasarathy and the research teams at all four institutions for the trust they have placed in us." - Van Morgan, CFO & Co-founder, Daybreak

Study findings are expected to inform clinical practice guidelines and treatment protocols for OSA on a national scale.

Editor's Note: The University of Arizona originally announced this study on May 13, 2026. The full announcement is available at: news.arizona.edu/news/new-study-help-inform-patient-physician-choices-sleep-apnea-treatment. Daybreak is issuing this release to recognize the study's significance and its role supporting the oral appliance therapy arm.

About Daybreak 

Daybreak is a sleep apnea solutions company helping patients diagnose and treat obstructive sleep apnea through at-home sleep testing and FDA-cleared mandibular advancement device therapy. Daybreak's model combines clinical rigor with patient accessibility, offering a streamlined pathway from diagnosis to treatment that meets patients where they are. Founded in 2022 and headquartered in Los Angeles, CA, Daybreak operates exclusively in the United States and partners with sleep physicians, DME providers, and federal healthcare institutions nationwide to extend access to evidence-based OSA care.

For additional information regarding Daybreak, please contact clinicalcare@thedaybreak.com.

About the Study

The PCORI-funded trial is led by Dr. Sairam Parthasarathy at the University of Arizona, with site principal investigators Dr. Clete Kushida (Stanford Medicine), Dr. Emerson Wickwire (University of Maryland School of Medicine), and Dr. Girardin Jean-Louis (University of Miami Miller School of Medicine). PCORI is an independent nonprofit that funds patient-centered comparative effectiveness research to help patients and clinicians make better-informed healthcare decisions. The original University of Arizona announcement is available at news.arizona.edu.

For additional information regarding this study, please contact:
Heidi Erickson, BSN, RN, CCRP
Director of Clinical Research & Regulatory Compliance
Division of Pulmonary, Critical Care & Sleep Medicine
University of Arizona
Email: herickso@arizona.edu
Phone: 520-626-5287

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SOURCE Daybreak