The Beginning of the AI-Enabled Preventative PAP Therapy Era: A First-in-Human Proof of Concept Interventional Study

Positive Airway Pressure (PAP) therapy is the most common and efficacious treatment for Obstructive Sleep Apnea (OSA). However, it suffers from poor patient adherence due to discomfort and may not fully alleviate all adverse consequences of OSA. Identifying abnormal respiratory events before they have occurred may allow for improved management of PAP levels, leading to improved adherence and better patient outcomes. Our previous work has resulted in the successful development of a Machine-Learning (ML) algorithm for the prediction of future apneic events using existing airflow and air pressure sensors available internally to PAP devices. Although researchers have studied the use of ML for the prediction of apneas, research to date has focused primarily on using external polysomnography sensors that add to patient discomfort and has not investigated the use of internal-to-PAP sensors such as air pressure and airflow to predict and prevent respiratory events. We hypothesized that by using our predictive software, OSA events could be proactively prevented while maintaining patients' sleep quality. An intervention protocol was developed and applied to all patients to prevent OSA events. Although the protocol's cool-down period limited the number of prevention attempts, analysis of 11 participants revealed that our system improved many sleep parameters, which included a statistically significant 31.6% reduction in Apnea-Hypopnea Index, while maintaining sleep quality. Most importantly, our findings indicate the feasibility of unobtrusive identification and unique prevention of each respiratory event as well as paving the path to future truly personalized PAP therapy by further training of ML models on individual patients.

I. Introduction

Obstructive sleep apnea (OSA) is a sleep-related respiratory disorder characterized by repetitive bouts of complete cessation or transient reduction in breathing with maintained or increasing respiratory effort [1]. OSA occurs when there is recurrent collapse of the pharyngeal airway during sleep as a result of excessive pharyngeal muscle relaxation leading to pharyngeal collapse and subsequent blockage of the upper airway [1]. This obstruction of the airway causes repetitive nocturnal oxyhemoglobin desaturation and nighttime awakenings [2]. The Apnea-Hypopnea Index (AHI) is the primary clinical measure of the severity of OSA and considers the frequency of hypopneas and apneas during each hour of sleep [2]. Hypopneas are periods of shallow breathing which occur because of partial airway blockage, while apneas are complete pauses in breathing due to full blockage of the airway [1], [3].