Sleep Apnea for Atrial Fibrillation

(DISCRETE AF Trial)

This trial explores how sleep disruption affects individuals with atrial fibrillation (AF), a heart condition causing irregular and often rapid heartbeats. It focuses on those with obstructive sleep apnea who use a device called HGNS (hypoglossal nerve stimulation) to keep their airways open during sleep. Participants will either use or not use their HGNS device on different nights over a 14-day period to observe its impact on heart rhythm. This trial suits individuals with an HGNS device implanted for sleep apnea, who receive care at UCSF Health, and are willing to follow specific instructions about device use. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance understanding and treatment of AF and sleep apnea.

If you are currently taking class 1 or 3 anti-arrhythmic medications, you cannot participate in the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Research has shown that hypoglossal nerve stimulation (HGNS) is generally well-tolerated. A review of studies found that individuals using HGNS for sleep apnea experienced fewer sleep disruptions and significant improvements in their condition. This treatment offers long-term benefits for those with moderate to severe sleep apnea by greatly reducing breathing problems during sleep.

Regarding safety, studies indicate that HGNS effectively reduces symptoms without major safety issues. The device stimulates a nerve in the tongue to keep the airway open during sleep, preventing collapse. Some patients might experience minor discomfort at the implantation site, but this is usually manageable.

Researchers are excited about the trial for treating sleep apnea in patients with atrial fibrillation because it explores a unique approach using Hypoglossal Nerve Stimulation (HGNS). Unlike standard treatments like CPAP machines, HGNS involves a surgically implanted device that stimulates the muscles of the airway, potentially offering a more comfortable and less cumbersome solution. This trial is particularly intriguing because it examines the impact of turning the HGNS device on and off, allowing researchers to directly observe changes in sleep apnea symptoms and their effects on atrial fibrillation. This could lead to more personalized and dynamic treatment strategies, which are not possible with current options.

Research has shown that stimulating the hypoglossal nerve (HGNS) can significantly improve sleep apnea by reducing breathing problems and enhancing sleep quality. For those with sleep apnea, HGNS effectively decreases episodes of interrupted breathing, leading to better sleep and overall health. In this trial, participants will join either the HGNS 'On' Case-Crossover Arm, using their HGNS device during sleep, or the HGNS 'Off' Case-Crossover Arm, not using the device. Although limited data links HGNS directly to controlling atrial fibrillation (AF), improved sleep might lower the risk of AF episodes by stabilizing heart rhythms. While HGNS is primarily used for sleep apnea, its impact on heart health remains under study.⁶⁷⁸⁹¹⁰