Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) expert and pioneering figure in the clinical application and research of hypoglossal nerve stimulation (HNS) to treat OSA, Ryan J. Soose, MD, associate professor of otolaryngology, has co-authored two new important publications providing guidance to clinicians for optimizing the postimplantation care of patients with OSA. The two new research papers,^1,2 recently published online in the journal Sleep, are featured in a special supplement with a companion editorial³ authored by guest editors Dr. Soose and University of Pittsburgh colleague Patrick J. Strollo, Jr, MD, FACP, FCCP, FAASM, from the Division of Pulmonary, Allergy and Critical Care Medicine.

Optimizing Post Implant Patient Care and Standardizing Treatment Pathways

The first paper from Dr. Soose and colleagues, titled “Post-Implant Care Pathway: Lessons Learned and Recommendations After 5 years of Clinical Implementation of Hypoglossal Nerve Stimulation,” serves as a guideline for optimizing postimplantation patient care for physicians in the United States and Europe who offer the therapy to patients with OSA.

HNS has rapidly expanded during the last decade with a tremendous amount of research and large-scale multicenter clinical trials providing clear evidence for the treatment's safety and efficacy (e.g., the phase III STAR trial and the global clinical ADHERE registry with more than 2,700 patients enrolled to date). 

“There are now more than 400 centers around the country implanting HNS devices in patients with OSA, representing thousands of individuals receiving this treatment. With the data that has been accumulated so far, we are now in a position to focus our clinical and research priorities on standardizing best-practice approaches to HNS therapy management in an effort to optimize patient comfort, effectiveness, and adherence to the treatment modality in order to achieve optimal long-term outcomes, particularly in those patients who have an incomplete response initially” says Dr. Soose.

The analysis provides physicians with a roadmap of management strategies and targeted interventions based upon a tiered framework that classifies patients by their response to HNS and associated issues or morbidities associated with the therapy. 

"For patients who receive HNS therapy to manage their OSA, about half respond well and have successful control of their sleep apnea with minimal or no side-effects. For the remainder of patients who have varying degrees of response or struggle with discomfort, developing and disseminating best practice guidelines and finding ways to optimize stimulation settings will likely lead to better long-term outcomes," says Dr. Soose. "The new framework we have put forth is a big step in that process."

Fine-Tuning HNS Post Implant Through Electrical Modeling

Accompanying the post-implant care pathway recommendations paper is another new study that is focused on helping physicians better understand the electrical modeling parameters and different programming settings of HNS implants in order to improve treatment results for patients and to set the stage for future research on optimizing device stimulation settings to achieve better control of OSA symptoms.

The paper, “Model-Based Analysis of Implanted Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea,” outlines the findings of Dr. Soose and colleagues in the development of a biophysical computational model to simulate and better understand the effects of varying HNS settings and configurations on the hypoglossal nerve. 

"Robust patient physiological evidence that would guide us in the use of specific stimulation settings to achieve optimal OSA control does not yet exist. This is a gap in our understanding that must be filled. This new paper outlines our use of modeling techniques to begin to better understand how various settings may ultimately affect the efficacy of HNS implants," says Dr. Soose.

The results from this study also point to the need for longitudinal follow-up and device adjustments as necessary to allow patients to maintain their OSA control levels. As patients live with the HNS implants for years, their response to initial device settings may change and require adjustment, among other factors. 

References

1. Soose RJ, Faber K, Greenberg H, Boon M, Woodson T, Strollo P. Post-Implant Care Pathway: Lessons Learned and Recommendations After 5 Years of Clinical Implementation of Hypoglossal Nerve Stimulation. SleepJ. 2021; S4-S10. Advance Access Publication Date: 12 December 2020. doi: 10.1093/sleep/zsaa279. Online ahead of print.

2. Johnson MD, Dweiri YM, Cornelius J, Strohl KP, Steffen A, Suurna M, Soose RJ, Coleman M, Rondoni J, Durand DM, Ni Q. Model-Based Analysis of Implanted Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea. SleepJ. 2021; S11-S19. Advance Access Publication Date: 27 February 2021. doi: 10.1093/sleep/zsaa269. Online ahead of print.

3. Post-Implant Management of Neurostimulation Therapy for OSA. SleepJ. 2021. S1-S3. Volume 44, Supplement 1. Guest Editors: Patrick J. Strollo Jr., MD, and Ryan J. Soose, MD. Editorial doi: 10.1093/sleep/zsab055.

More About Dr. Soose

Ryan J. Soose, MD, is the director of the UPMC Sleep Division and an associate professor in the Department of Otolaryngology at the University of Pittsburgh School of Medicine. He earned his undergraduate degree from the University of Notre Dame and then completed medical and surgical training at UPMC and the University of Pittsburgh, subsequently joining the Department as a faculty member at the end of his sleep fellowship.

Board-certified in both otolaryngology and sleep medicine, Dr. Soose specializes in the medical and surgical treatment of sleep-disordered breathing. He is actively engaged with sleep research, a robust clinical practice, national and international academic organizations, and the training of residents, fellows, and medical students.