A five-year, nearly $14 million award from the Patient-Centered Outcomes Research Institute (PCORI) will fund a major clinical trial led by the University of Arizona, examining three common treatments for obstructive sleep apnea, which affects approximately 12% of the U.S. population. This condition involves the airway repeatedly collapsing during sleep, leading to disrupted breathing and increasing the risks of excessive daytime sleepiness, high blood pressure, and cardiovascular disease.
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Dr. Sairam Parthasarathy, director of the Center for Sleep, Circadian & Neuroscience Research and a professor of medicine at the College of Medicine – Tucson, will lead the trial. He noted, "Sleep apnea can significantly affect quality of life and is costly to the workforce through lost productivity." The clinical trial aims to clarify the benefits and limitations of three treatment options to determine which is most effective for each patient.
An estimated 47 million Americans have some form of sleep apnea, with about 10 to 12 million using continuous positive airway pressure (CPAP) therapy. The study will compare CPAP, a dental device that keeps the airway open, and a medication combining atomoxetine and oxybutynin. Each treatment has potential side effects: CPAP may lead to skin irritation and bloating, dental devices can cause jaw discomfort, and the pill therapy may result in insomnia and urinary retention.
Researchers will assess treatment effectiveness through various measures, such as daytime sleepiness levels, blood pressure, treatment adherence, and patient-reported quality of life, alongside changes in the apnea-hypopnea index, a standard diagnostic measure for sleep apnea severity.
The study aims to enroll 2,400 participants with obstructive sleep apnea, evaluating their progress over 12 months. Recruitment will be facilitated by a patient advocacy group to ensure a diverse study population. Main study sites will be located at the University of Arizona in Tucson, along with additional sites at the University of Miami, University of Maryland, and Stanford Medicine.
The study's findings are expected to inform both patients and clinicians on effective and cost-efficient treatment options. Parthasarathy emphasized the importance of stakeholder engagement in designing the trial, stating, "Engaging stakeholders helps ensure the study addresses real-world decision-making." This collaborative effort aims not to declare one therapy superior but to facilitate informed decisions that match the right treatment with the right patient. The trial will also involve principal investigators from leading institutions, enhancing the study's methodological rigor and impact on sleep medicine.