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Peerbridge Health’s Successful Clinical Trial Unveils Direct-from-ECG Sleep Apnea Detection Using COR Wearable Platform

Peerbridge Cor Capabilities adds sleep apnea detection and shows device packaging

Peerbridge Health is pleased to announce the successful completion and findings of its prospective, feasibility clinical trial, resulting in a statistically significant 91.2% predictive accuracy for the determination of apnea-hypopnea index (AHI) for diagnosing obstructive sleep apnea (OSA) while using the Peerbridge CorTM. This device is a patented 3-lead, 2-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 undiagnosed1, and doubles the risk for heart failure and other serious cardiovascular conditions. OSA is commonly seen in patients with arrhythmias like atrial fibrillation (AFib) and due to the variable unpredictable nature of sleep apnea symptoms, it is often untreated, leading to adverse outcomes.  

This progressive study establishes Peerbridge Cor’s capability to calculate AHI directly from ECG waveforms with equivalent accuracy to AHI measurements derived from an FDA-approved at-home sleep apnea test. AHI is accepted as a compliance, efficacy, and effectiveness metric for continuous positive airway pressure (CPAP) and other OSA therapies. The achievement follows the recent announcement of Cor’s capability to capture real-time, AI-enabled on-demand ejection fraction (EF).  

This clinical trial cohort included participants aged 24 to 70, with diagnosed co-morbidities that included OSA, asthma, diabetes, obesity hypertension, Heart Failure (HF) 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. 

Undiagnosed and untreated sleep apnea increases the risk of costly health complications like heart disease, hypertension, diabetes, and depression. Studies estimated that identifying and treating every patient in the U.S. affected by sleep apnea could generate a yearly economic savings of $100.1 billion2. The completion of this trial has demonstrated that Peerbridge Cor can accurately measure AHI to improve patients’ lives and contribute to the effort of reducing healthcare costs across the United States.  

Building upon these Trial Results, Peerbridge Health plans to launch a prospective, multi-center, pivotal trial early 2024 to seek FDA Clearance for a Home Sleep Test (HST) for screening, diagnosing, and tracking effectiveness of CPAP and other devices approved for OSA therapy.  

1American Heart Association (2021). Sleep apnea worsens heart disease, yet often untreated. Retrieved from   

2 Kingshott, R. (2017, November 8). Economic burden of undiagnosed sleep apnea in U.S. is nearly $150B per year. American Academy of Sleep Medicine – Association for Sleep Clinicians and Researchers.  

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