AI-Enabled Solutions In Sleep Medicine Advancing OSA Diagnosis

Innovations in Pulmonology, Critical Care & Sleep Medicine | Winter 2024

More than 30 million adults in the United States are believed to have obstructive sleep apnea (OSA), although only about 6 million have been diagnosed. The comorbidities related to OSA, and the impacts on patients’ lives, are significant, so the search for better diagnostic tools and treatments for OSA is urgent.

Ambrose Chiang, MD, FACCP, FAASM

Ambrose Chiang, MD, FCCP, FAASM, senior attending sleep specialist at University Hospitals (UH) Cleveland Medical Center, has been actively conducting validation studies with wearable devices to streamline OSA diagnosis.

Dr. Chiang has launched a new clinical trial to evaluate the latest iteration of Belun Ring platform, a wearable device developed by Belun Technology Company Ltd.

Belun Ring and Cor

“The Belun Ring is a wearable device that integrates Artificial Intelligence (AI) to help clinicians diagnose OSA and classify sleep stages,” Dr. Chiang says. “During a home sleep study, patients wear a ring-shaped device, equipped with a pulse oximeter and accelerometer, on the proximal index finger. The ring measures autonomic nervous system activity, computes an apnea-hypopnea index and distinguishes sleep stages between wake, REM and NREM sleep. The new Belun Ring, with its latest AI algorithms, can now be coupled with the novel Belun Cor, a subxiphoid body sensor that detects respiratory efforts and body position. This combination can potentially enhance the differentiation between obstructive and central sleep apnea, a crucial advancement in accuracy as many wearable devices struggle to reliably make this distinction.”

This clinical trial, which will enroll about 80 patients from the UH sleep labs, began in March 2024 and will run four to six months. The primary goals of this trial are to evaluate the performance of the new third-generation Belun deep-learning algorithms coupled with Belun Cor sensor compared to in-lab plethysmography (PSG), the gold standard for OSA detection.

UH is hoping to get answers to some important secondary questions as well, says Dr. Chiang, including determining the accuracy of the new algorithms in detecting arrhythmias and exploring whether specific sleep biomarkers, at baseline or their changes during a split-night study, can forecast CPAP compliance. Dr. Chiang expects the trial to also offer insights on how many hours of recorded sleep data are needed for an accurate diagnosis when using wearables at home and to assess the performance of some emerging AI-based OSA screening tools using predictive models developed at other institutions.

Looking Ahead

This new study comes on the heels of two earlier UH investigations with the Belun Ring, which employs state-of-the-art, deep-learning-powered sleep technologies for both sleep state detection and OSA diagnosis.  

“Over the past four years, the FDA has cleared nine wearable platforms for home OSA testing, each with unique operating mechanisms for which accuracy varies,” Dr. Chiang says. “Among these, the Belun Ring shows significant promise. Our recently published performance evaluation study using the second-generation Belun algorithms demonstrated high accuracy in detecting moderate to severe OSA. This new study, utilizing the Belun Ring and Belun Cor, will help us determine if this new combination offers enhanced efficacy and precision compared to earlier iterations. It will also help us understand how best to apply some of the novel biomarkers metrics, such as pulse rate variability, hypoxic burden, or delta heart rate, in clinical practice.

“The landscape of sleep medicine practice is experiencing rapid transformation. Digital sleep health will no doubt enhance medical care accessibility and offer more precise and personalized medicine. We anticipate and hope that the insights gained from this pivotal study will help revamp the diagnosis and management of sleep apnea in the next decade.”

For more information about this study, contact Dr. Chiang at 216-844-7378.

Contributing Expert
Ambrose Chiang, MD, FCCP, FAASM
Senior Attending Sleep Specialist
University Hospitals Cleveland Medical Center
Cleveland VA Medical Center
Clinical Associate Professor
Case Western Reserve University School of Medicine