News | Cardiovascular Clinical Studies | December 19, 2023

Clinical Trial Results from Peerbridge Health Unveil Direct-from-ECG Sleep Apnea Detection Using COR Wearable Platform

Peerbridge Health has announced 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 Cor, 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.

Peerbridge Health has announced 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 Cor, 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. Image courtesy: Peerbridge Health

 


December 19, 2023 — Peerbridge Health has 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 Cor. The 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 undiagnosed (1) , 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.

“Optimal treatment of cardiovascular disease requires clinicians to address critical co-morbid conditions such as sleep apnea,” said Nicholas Skipitaris, M.D., Western Regional Director of Cardiac Electrophysiology, Northwell Health, NY. “Using Peerbridge Cor, we can for the first time simultaneously diagnose cardiac rhythm disorders, obstructive sleep apnea, and structural heart disease with one easy-touse 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,” Skipitaris added.

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 billion (2).

The statement issued on the study outcomes reported that completion 2/2 of the 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.

“Peerbridge Health continues to innovate by compounding clinical utility in one simple device," said Andrea Natale, M.D., FACC, FHRS, FHSC, Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David's Medical Center. "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," added Natale.

“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,” said Chris Darland, Peerbridge Health President & CEO. He continued, "Following successful trials for Ejection Fraction and Heart Failure, I'm pleased to include OSA to our suite of clinical tools available from the Cor device. This is just the beginning of our journey in remote diagnostics and is part of a larger mission to become a trusted source for physicians and patients, anytime, anywhere.”

Building upon these Trial Results, Peerbridge Health plans to launch a prospective, multi-center, pivotal trial early 2024 to seek U.S. Food and Drug Administration (FDA) Clearance for a Home Sleep Test (HST) for screening, diagnosing and tracking effectiveness of CPAP and other devices approved for OSA therapy, according to the written statement released by the company.

The company reinforced that it is working to transform remote healthcare with an advanced AI-driven ECG platform that predicts and diagnoses the top chronic illnesses affecting people today. To that end, it combines innovative wearable AECG technology with superior recording fidelity and proprietary algorithms to capture a wide range of vital health diagnostics, making it simpler, faster, and more accurate to remotely diagnose and treat patients.

More information: www.peerbridgehealth.com

Reference:

1. American Heart Association (2021). Sleep apnea worsens heart disease, yet often untreated. Retrieved from https://newsroom.heart.org/news/sleep-apnea-worsens-heart-disease-yet-often-untreated

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. https://aasm.org/economic-burden-of-undiagnosed-sleepapnea-in-u-s-is-nearly-150b-per-year/


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