Sleep Medicine Advances at UPMC: New Research and Clinical Advances

Disruptions to sleep and sleeping patterns can have profound consequences on overall health and well-being. There are nearly 80 different kinds of sleep disorders, with obstructive sleep apnea (OSA) being one of the most common. These sleep disorders often coexist in clusters, and many individuals have comorbid conditions that can significantly affect their ability to achieve quality sleep, such as chronic obstructive pulmonary disorder (COPD), fibromyalgia, heart disease, and even traumatic brain injuries (TBI, or mild traumatic brain injuries (mTBI) like concussions.

Ryan J. Soose, MD, is the director of the UPMC Department of Otolaryngology's Sleep Division. Dually-trained in both otolaryngology and sleep medicine, Dr. Soose treats patients across the full spectrum of sleep disturbances. He has a particular emphasis on OSA with pioneering work in the use of hypoglossal nerve pacing, or upper airway stimulation (UAS) therapy, for refractory OSA. Dr. Soose has actively led UAS research studies over the last decade, including the landmark multicenter Stimulation Treatment for Apnea Reduction (STAR) clinical trial that investigated short- and long-term benefits and outcomes of hypoglossal nerve stimulation therapy for difficult to treat cases of OSA.

Dr. Soose's OSA research has continued to apply UAS in the pediatric Down syndrome population to develop a post-implant care pathway for the long-term management of electrical stimulation parameters, and the ‘ADHERE’ registry. The ADHERE registry is a multicenter international clinical registry, with a goal enrollment of 5,000 UAS patients, to better analyze UAS outcomes and predictors of success in large populations. Dr. Soose presented results on the first 1,000 ADHERE registry patients at the 2019 American Academy of Otolaryngology-Head & Neck Surgery (AAO-HNS) annual meeting. 

Additionally, Dr. Soose has been an investigator on the University of Pittsburgh's TEAM-TBI study, a large prospective study on traumatic brain injury funded by the U.S. Department of Defense (DOD). He has collaborated with Department chair Jonas Johnson, MD, FACS, and the Head and Neck Cancer Survivorship Clinic, to analyze patient-reported outcome measures for sleep in cancer survivors. Head and neck cancers, and the treatments designed to manage or cure them, can affect survivors profoundly. Sleep is but one of the ways these patients' lives may be altered by their cancer and subsequent treatment, but it is an important aspect of follow-up care that can be lacking, hence the greater focus placed on screening for sleep disorders in these patients. Improving the sleep quality of cancer patients and TBI patients can have a multitude of benefits in other areas of health, including improved mood, immune function, cognitive function, pain management, cardiovascular health, and general quality of life.

“While OSA and UAS therapy have been a large focus of my clinical practice and research, the Department is involved in much more sleep-related work than people may realize, for example with the Survivorship Clinic and our collaborative work in TBI. Sleep is such a complex area of human physiology; there is no aspect of one's health and physical functioning that is not affected when individuals have difficulty sleeping, regardless of the underlying causes. Sleep medicine is such a rich and rewarding field to be involved in, and our programs continue to expand both clinically and at the frontiers of research,” says Dr. Soose.

Results from the ADHERE Registry: Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea

Dr. Soose, and the Department, have been involved with one of the largest registries studying patients with obstructive sleep apnea who have undergone some form of neurostimulation to treat their condition.

The Adherence and Outcome of Upper Airway Stimulation for OSA (ADHERE)¹ registry is an international multicenter effort that follows patients in a prospective observational study, tracking their outcomes after having upper airway stimulation therapy for their OSA. 

"The ADHERE study has a goal of recruiting 5,000 patients by the end of its protocol. Most of these kinds of studies in the past have been relatively small in size. In the paper that the study group published in May 2020, and which we presented preliminary results in the Fall of 2019 at AAO, we report on findings from the first thousand enrolled individuals. This is a big step for the field in terms of analyzing outcomes, compliance, and other patient metrics," says Dr. Soose.

Results from the first ADHERE registry paper indicate that patients who have UAS therapy to treat their obstructive sleep apnea show improvements across a spectrum of outcomes, and that in long-term follow-up, these results have proved to be durable, and patient adherence to the therapy remains at a high level.

Measures related to the Apnea-Hypopnea Index (AHI) showed significant reductions over baseline measures at both 6 and 12 months postdevice implantation. Patients also reported less daytime sleepiness, and various patient satisfaction measures recorded by participants were all at levels of 90% and above.

"We are still very early in the life of the ADHERE registry, but our results so far are quite promising, and there is still much we are going to learn as this study progresses over the coming years. I suspect that when we reach our endpoints, we will have very robust data that supports the use of upper airway stimulation to effectively treat OSA for long periods," says Dr. Soose.

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.

Dr. Soose is dually board-certified in otolaryngology and sleep medicine. His clinical and research specialties are in the medical and surgical treatment of snoring and obstructive sleep apnea. He is an active member of the American Academy of Otolaryngology-Head & Neck Surgery (AAO-HNS), the American Academy of Sleep Medicine (AASM), and the International Surgical Sleep Society (ISSS). Dr. Soose has a special interest in sedated endoscopy and neurostimulation therapy (hypoglossal nerve pacing) in the management of patients with sleep apnea.

References

1. Thaler E, Schwab R, Maurer J, Soose R, Larsen C, Stevens S, Stevens D, Boon M, Huntley C, Doghramji K, Waters T, Kominsky A, Steffen A, Kezirian E, Hofauer B, Sommer U, Withrow K, Strohl K, Heiser C. Results of the ADHERE Upper Airway Stimulation Registry and Predictors of Therapy Efficacy. Laryngoscope. 2020 May; 130(5): 1333-1338.

Further Reading

Below are the most recent research papers (2019-2020) Dr. Soose has coauthored related to his sleep research. 

Soose RJ, Faber K, Greenberg H, Boon M, Woodson BT, Strollo PJ.  Post-implant Care Pathway: Lessons Learned and Recommendations After 5 Years of Clinical Implementation of Hypoglossal Nerve Stimulation Therapy. Sleep. Accepted for publication December 2020.

Johnson MD, Dweiri Y, Cornelius J, Strohl KP, Steffen A, Suurna M, Soose RJ, Coleman M, Rondoni J, Duran D, Ni Q.  Model-based Analysis of Implanted Hypoglossal Nerve Stimulation for the Treatment Of Obstructive Sleep Apnea. Sleep. Accepted for publication December 2020.

Yu PK, Jayawardena ADL, Stenerson M, Pulsifer MB, Grieco JA, Abbeduto L, Dedhia RC, Soose RJ, Tobey A, Raol N, Ishman SL, Shott SR, Cohen MS, Skotko BG, Kinane TB, Keamy DG, Hartnick CJ.  Redefining Success by Focusing on Failures After Pediatric Hypoglossal Stimulation in Down syndrome. Laryngoscope. 2020 Dec 2.

Thaler E, Schwab R, Maurer J, Soose R, Larsen C, Stevens S, Stevens D, Boon M, Huntley C, Doghramji K, Waters T, Kominsky A, Steffen A, Kezirian E, Hofauer B, Sommer U, Withrow K, Strohl K, Heiser C. Results of the ADHERE Upper Airway Stimulation Registry and Predictors of Therapy Efficacy. Laryngoscope. 2020 May; 130(5): 1333-1338. 

Larsen C, Boyd C, Villwock M, Steffen A, Heiser C, Boon M, Huntley C, Doghramji K, Soose RJ, Kominsky A, Waters T, Withrow K, Parker N, Thaler E, Dhanda Patil R, Green KK, Chio E, Suurna M, Schell A, Strohl K. Evaluation of Surgical Learning Curve Effect on Obstructive Sleep Apnea Outcomes in Upper Airway Stimulation. Ann Otol Rhinol Laryngol. 2020 Sep 13: 3489420958733.

Mehra R, Steffen A, Heiser C, Hofauer B, Withrow K, Doghramji K, Boon M, Huntley C, Soose RJ, Stevens S, Larsen C, Maurer JT, Waters T, Walia HK, Kominsky AH, Trask D, Schwab RJ, Thaler ER, Strollo PJ Jr; ADHERE Registry Study. Upper Airway Stimulation Versus Untreated Comparators in Positive Airway Pressure Treatment Refractory Obstructive Sleep Apnea. Ann Am Thorac Soc. 2020 Jul 14. doi: 10.1513/AnnalsATS.202001-015OC. Online ahead of print.

Whelan R, Soose RJ. Implantable Neurostimulation for Treatment of Sleep Apnea: Present and Future. Otolaryngol Clin North Am. 2020 Jun; 53(3): 445-457. 

Freiser ME, Schell AE, Soose RJ. DISE-PAP: A Method for Troubleshooting Residual AHI Elevation Despite Positive Pressure Therapy. J Clin Sleep Med. 2020 Apr 15; 16(4): 631-633.

Caloway CL, Diercks GR, Keamy D, de Guzman V, Soose R, Raol N, Shott SR, Ishman SL, Hartnick CJ. Update on Hypoglossal Nerve Stimulation in Children With Down Syndrome and Obstructive Sleep Apnea. Laryngoscope. 2020 Apr; 130(4): E263-E267. 

Cillo AR, Kürten CHL, Tabib T, Qi Z, Onkar S, Wang T, Liu A, Duvvuri U, Kim S, Soose RJ, Oesterreich S, Chen W, Lafyatis R, Bruno TC, Ferris RL, Vignali DAA. Immune Landscape of Viral- and Carcinogen-Driven Head and Neck Cancer. Immunity. 2020 Jan 14; 52(1): 183-199.e9.

Kezirian EJ, Heiser C, Steffen A, Boon M, Hofauer B, Doghramji K, Maurer JT, Sommer JU, Soose RJ, Schwab R, Thaler E, Withrow K, Kominsky A, Larsen CG, Hsia J, Mehra R, Waters T, Strohl K. Previous Surgery And Hypoglossal Nerve Stimulation For Obstructive Sleep Apnea. Otolaryngol Head Neck Surg. 2019 Nov; 161(5): 897-903. 

Mesley MS, Edelman K, Sharpless J, Borrasso A, Billigen JB, Puffer R CPT MC USA, Williams D, Benso S, Puccio AM, Schneider W, Soose R, Beers S, Kontos A, Collins M, Okonkwo DO. Impact of Multi-Disciplinary Care and Clinical Coach Coordinators on Participant Satisfaction and Retention in TBI Clinical Trials: A Team-TBI Study. Mil Med. 2019 Mar 1; 184(Suppl 1): 155-159. 

Green KK, Kent DT, D’Agostino MA, Hoff PT, Lin HS, Soose RJ, Gillespie MB, Yaremchuk KL, Carrasco-Llatas M, Woodson BT, Jacobowitz O, Thaler ER, Barrera JE, Capasso R, Liu SY, Hsia J, Mann D, Meraj TS, Waxman JA, Kezirian EJ.  Drug-Induced Sleep Endoscopy and Surgical Outcomes: A Multicenter Cohort Study. Laryngoscope. 2019 Mar; 129(3): 761-770. 

Heiser C, Steffen A, Boon M, Hofauer B, Doghramji K, Maurer JT, Ulrich Sommer J, Soose R, Strollo PJ, Schwab R, Thaler E, Withrow, Kominsky A, Larzen C, Kezirian EJ, Hsia J, Chia S, Harwick J, Strohl K, Mehra R; ADHERE Registry Investigators. Post-approval Upper Airway Stimulation Predictors of Treatment Effectiveness in the ADHERE Registry. Eur Respir J. 2019 Jan 3; 53(1).

Vasconcellos AP, Huntley CT, Schell AE, Soose RJ, Boon MS. Dysfunctional Hypoglossal Nerve Stimulator After Electrical Cardioversion: A Case Series. Laryngoscope. 2019 Aug; 129(8): 1949-1953.