A clinical trial has shown Peerbridge Health’s wearable device, the Peerbridge Cor, is capable of detecting obstructive sleep apnea (OSA), alongside cardiac rhythm and structural heart diseases, with high accuracy from the patients’ homes.
The trial reported 91.2% accuracy for the determination of the apnea-hypopnea index (AHI) for diagnosing OSA.
This device is a patented three-lead, two-channel wireless continuous ECG wearable device that allows physicians the ability to address and assess sleep and heart health remotely.
OSA disproportionately affects the 92 million Americans living with cardiovascular disease (CVD), often goes undiagnosed, and doubles the risk for heart failure and other serious cardiovascular conditions, according to a release from Peerbridge Health.
“Optimal treatment of cardiovascular disease requires clinicians to address critical co-morbid conditions such as sleep apnea,” says Nicholas Skipitaris, MD, western regional director of cardiac electrophysiology at Northwell Health, in a release. “Using Peerbridge Cor, we can for the first time simultaneously diagnose cardiac rhythm disoratrders, obstructive sleep apnea, and structural heart disease with one easy-to-use device that patients can wear at home. Physicians and patients benefit from greatly enhanced clinical value with a streamlined workflow that creates no incremental effort for our medical staff.”
This progressive study establishes Peerbridge Cor’s capability to calculate AHI directly from ECG waveforms with equivalent accuracy to AHI measurements derived from a US Food and Drug Administration (FDA)-approved at-home sleep apnea test. The results follow the recent announcement of Cor’s capability to capture real-time, artificial intelligence (AI)-enabled on-demand ejection fraction.
“Peerbridge Health continues to innovate by compounding clinical utility in one simple device,” says Andrea Natale, MD, executive medical director at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, in a release. “Leveraging powerful AI technology to deliver novel direct-from-ECG ejection fraction, heart failure, and now OSA diagnostics, the Peerbridge Cor is quickly becoming a transformative multipurpose diagnostic tool, facilitating early interventions that will enhance the quality of life for our cardiovascular patients.”
This clinical trial cohort included participants aged 24 to 70 with diagnosed co-morbidities that included OSA, asthma, diabetes, obesity hypertension, heart failure, and hyperthyroidism.
Peerbridge Cor achieved perfect accuracy for detecting sleep apnea in patients categorized with either no OSA or severe OSA, aligning with the FDA-approved at-home sleep apnea test, according to a release from the company.
“We are encouraged by the results of this feasibility trial, demonstrating our ability to offer a solution that links cardiac and sleep conditions, providing a more holistic and comprehensive approach to improving the lives of patients,” says Chris Darland, Peerbridge Health president and CEO, in a release.
Building upon these trial results, Peerbridge Health plans to launch a prospective, multi-center, pivotal trial in early 2024 to seek FDA clearance for a home sleep test for screening, diagnosing, and tracking the effectiveness of CPAP and other devices approved for OSA therapy.
Photo caption: Peerbridge Cor
Photo credit: Peerbridge Health