Major Study to Compare Sleep Apnea Treatments in Landmark Clinical Trial
In a significant move to better understand and treat obstructive sleep apnea, a condition affecting roughly 12% of Americans, the University of Arizona will lead a clinical trial backed by a substantial $14 million grant from the Patient-Centered Outcomes Research Institute (PCORI). This five-year study will compare three prevalent treatments for this disorder, which can lead to serious health issues like cardiovascular disease and high blood pressure.
Obstructive sleep apnea, characterized by repeated airway collapse during sleep, has far-reaching effects on health and daily life. “Sleep apnea can significantly affect quality of life and is costly to the workforce through lost productivity,” said Dr. Sairam Parthasarathy, director of the Center for Sleep, Circadian & Neuroscience Research and professor of medicine at the College of Medicine – Tucson. “Each of the three available therapies has benefits and downsides. Our goal is to understand which treatment works best for an individual patient.”
PCORI, a nonprofit dedicated to funding patient-centered research, has previously supported Parthasarathy’s work on adherence to CPAP (continuous positive airway pressure) therapy. The trial will examine CPAP, a dental device, and a combination oral medication to determine their effectiveness and suitability for different patients.
Understanding Treatment Options
The study will involve 2,400 participants with obstructive sleep apnea, who will be monitored over a year. The treatments being compared include CPAP, which uses a mask to deliver air pressure, a dental device that maintains an open airway, and a medication that combines atomoxetine and oxybutynin. Each option has its own set of potential side effects, such as CPAP-related skin irritation or the pill therapy causing insomnia.
Participants will be assessed based on various factors including daytime sleepiness, blood pressure, adherence to treatment, and quality of life. The research team will also measure changes in the apnea-hypopnea index, a key diagnostic metric for sleep apnea severity. “Our ultimate measure is health and quality of life, as reported by patients themselves,” Parthasarathy explained.
Collaborative Efforts and Broader Impact
In addition to the University of Arizona, the trial will be conducted at other reputable institutions including the University of Miami, the University of Maryland, and Stanford Medicine. The study aims to answer crucial questions such as which patients respond best to which treatment, and whether specific therapies are more effective for certain types of sleep apnea or different demographics.
Stakeholder engagement is a cornerstone of the trial design, involving input from physicians, patients, insurers, and policymakers. “Engaging stakeholders helps ensure the study addresses real-world decision-making. The results have the potential to influence how patients and physicians choose treatments,” said Parthasarathy. “Our goal is not to declare one therapy superior to the others. We want to match the right treatment to the right patient so people and their physicians can make informed decisions.”
Dr. Parthasarathy highlighted the importance of collaboration in this large-scale study, acknowledging the contributions of principal investigators like Dr. Clete Kushida at Stanford Medicine and Emerson Wickwire at the University of Maryland. “It is tremendously valuable to bring together the complementary expertise and deep scientific knowledge of site principal investigators from leading institutions to guide a multi-center randomized clinical trial in a critical area of sleep science,” he said.
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